List of Anti-Cancer Drugs Aproved by The FDA - PharmaKnow

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.
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Drug
Drug Trade Name
Approved Use
Manufacturer/Distributor
Approval Date
abarelix
Plenaxis depot
aldesleukin Aldesleukin
Prokine Proleukin
Alemtuzumab
Campath
alitretinoin
Panretin
allopurinol
Zyloprim
1 of 39
For the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological Praecis compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia Treatment of adults with Chiron metastatic melanoma Treatment of adults with metastatic renal cell Chiron Corp carcinoma Accel. Approv. (clinical benefit not established) Campath is indicated for the treatment of B-cell chronic lymphocytic Millennium and ILEX leukemia (B-CLL) in Partners, LP patients who have been treated with alkylating agents and who have failed fludarabine therapy. Topical treatment of cutaneous lesions in Ligand Pharmaceuticals patients with AIDS-related Kaposis sarcoma. Patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer GlaxoSmithKline therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. Single agent palliative treatment of patients
Nov 25 2003
Jan 09 1998 May 05 1992
May 07 2001
Feb 02 1999
May 17 1996
1/11/2014 6:58 PM
List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com
altretamine
Hexalen
amifostine
Ethyol
amifostine
Ethyol
amifostine
Ethyol
anakinra
Kineret
anastrozole
Arimidex
anastrozole
Arimidex
anastrozole
Arimidex
2 of 39
oral therapy. Single agent palliative treatment of patients with persistent or recurrent ovarian cancer US Bioscience following first-line therapy with a cisplatin and/or alkylating agent based combination. To reduce the cumulative renal toxicity associated with repeated US Bioscience administration of cisplatin in patients with advanced ovarian cancer Accel. Approv. (clinical benefit not established) Reduction of platinum US Bioscience toxicity in non-small cell lung cancer To reduce post-radiation xerostomia for head and neck cancer where the US Bioscience radiation port includes a substantial portion of the parotid glands. pediatric Use section of the US product label and to fulfill PMC #3 to assess the safety and Amgen efficacy of anakinra in pediatric patients with juvenile rheumatoid arthritis Accel. Approv. (clinical benefit not established) for the adjuvant treatment of AstraZeneca postmenopausal women with hormone receptor positive early breast cancer Conversion to regular approval for the adjuvant treatment of postmenopausal women AstraZeneca with hormone receptor positive early breast cancer Treatment of advanced breast cancer in postmenopausal women AstraZeneca with disease progression Pharmaceuticals following tamoxifen
Dec 26 1990
Dec 08 1995
Mar 15 1996
Jun 24 1999
Dec 15 2006
Sep 05 2002
Sep 16 2005
Dec 27 1995
1/11/2014 6:58 PM
anastrozole
Arimidex
anastrozole
Arimidex
arsenic trioxide
Trisenox
asparaginase
Elspar
Asparaginase
Elspar
azacitidine
Vidaza
3 of 39
p p with disease progression Pharmaceuticals following tamoxifen therapy. For first-line treatment of postmenopausal women with hormone receptor positive or AstraZeneca hormone receptor Pharmaceuticals unknown locally advanced or metastatic breast cancer. Second line treatment of relapsed or refractory Cell Therapeutic APL following ATRA plus an anthracycline. Therapy of patients with acute lymphocytic Merck leukemia ELSPAR is indicated in the therapy of patients with acute lymphocytic leukemia. This agent is useful primarily in Merck & Co, Inc combination with other chemotherapeutic agents in the induction of remissions of the disease in pediatric patients. For use for the treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by Pharmion neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with
1995
Sep 01 2000
Sep 25 2000 Jan 10 1978
Aug 01 2002
May 19 2004
1/11/2014 6:58 PM
azacitidine
Vidaza
syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by Pharmion neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. Organon Teknika Corp Metastatic colon Genentech carcinoma FDA approved changed in the Avastin package insert regarding warning and dose and administration for Reversible Posterior Genentech Leukoencephalopathy Syndrome. Nasal septum perforation was also added as a serious adverse event. a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell Genentech lung cancer in combination with platinum-based chemotherapy First-line treatment of patients with metastatic carcinoma of the colon and rectum (in Genentech combination with intravenous 5-fluorouracil-based chemotherapy) For the treatment by oral capsule of cutaneous manifestations of cutaneous T-cell Ligand Pharmaceuticals lymphoma in patients who are refractory to at least one prior systemic therapy. For the topical treatment
Jan 26 2007
BCG Live bevacizumab
TICE BCG Avastin
Aug 21 1998 Jun 20 2006
bevacizumab
Avastin
Sep 21 2006
bevacizumab
Avastin
Oct 11 2006
bevacuzimab
Avastin
Feb 26 2004
bexarotene capsules
Targretin
Dec 29 1999
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bexarotene gel
Targretin
least one prior systemic therapy. For the topical treatment of cutaneous manifestations of cutaneous T-cell Ligand Pharmaceuticals lymphoma in patients who are refractory to at least one prior systemic therapy. Bristol-Myers Squibb Sclerosing agent for the treatment of malignant pleural effusion (MPE) and prevention of recurrent pleural effusions. for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy Accel. Approv. (clinical benefit not established) for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy Conversion to regular approval for treatment of multiple myeloma patients who have received as least one prior therapy Use in combination with cyclophoshamide as conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Chronic Myelogenous Leukemia- palliative therapy
Jun 28 2000
bleomycin
Blenoxane
Jul 31 1973
bleomycin
Blenoxane
Bristol-Myers Squibb
Feb 20 1996
bortezombi
Velcade
Millennium
Dec 08 2006
bortezomib
Velcade
Millenium
May 13 2003
bortezomib
Velcade
Millenium
Mar 25 2005
busulfan intravenous
Busulfex
Orphan Medical, Inc
Feb 04 1999
busulfan oral calusterone
Myleran Methosarb
GlaxoSmithKline Pharmacia & Upjohn Company
Jun 26 1954 Feb 20 1973
5 of 39
Accel. Approv. (clinical
1/11/2014 6:58 PM
calusterone
Methosarb
Pharmacia & Upjohn Company Accel. Approv. (clinical benefit subsequently established) Treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel Roche and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents Initial therapy of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination Roche chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5_FU/LV has not been demonstrated with Xeloda monotherapy. Conversion to regular approval for treatment in combination with docetaxel of patients with metastatic breast Roche cancer after failure of prior anthracycline containing chemotherapy Adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary Roche tumor when treatment with fluoropyrimidine therapy alone is preferred Palliative treatment of patients with ovarian carcinoma recurrent after prior
Feb 20 1973
capecitabine
Xeloda
Apr 30 1998
capecitabine
Xeloda
Apr 30 2001
capecitabine
Xeloda
Sep 07 2001
capecitabine
Xeloda
Jun 15 2005
6 of 39
Mar 03 1/11/2014 6:58 PM
carboplatin
Paraplatin
carboplatin
Paraplatin
patients with ovarian carcinoma recurrent after prior Bristol-Myers Squibb chemotherapy, including patients who have been previously treated with cisplatin. Initial chemotherapy of advanced ovarian carcinoma in combination with other Bristol-Myers Squibb approved chemotherapeutic agents. Bristol-Myers Squibb Treatment of patients with malignant glioma MGI Pharma undergoing primary surgical resection For use in addition to surgery to prolong survival in patients with Guilford Pharmaceuticals recurrent glioblastoma Inc. multiforme who qualify for surgery. Accel. Approv. (clinical benefit not established) Reduction of polyp number in patients with Searle the rare genetic disorder of familial adenomatous polyposis. Accel. Approv. (clinical benefit not established) for treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in Imclone combination with irinotecan); as a single agent, treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy For use in combination with radiation therapy (RT) for the treatment of
Mar 03 1989
Jul 05 1991
carmustine
BCNU, BiCNU
Mar 07 1977 Feb 25 2003
carmustine
Gliadel
carmustine with Polifeprosan 20 Implant
Gliadel Wafer
Sep 23 1996
celecoxib
Celebrex
Dec 23 1999
cetuximab
Erbitux
Feb 12 2004
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cetuximab
Erbitux
with radiation therapy (RT) for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) or as Imclone a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. GlaxoSmithKline Metastatic testicular-in established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors whoc have Bristol-Myers Squibb already received appropriate surgical and/or radiotherapeutic procedures. An established combination therapy consists of Platinol, Blenoxane and Velbam. Metastatic ovarian tumors - in established combination therapy with other approved chemotherapeutic agents: Ovarian-in established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received Bristol-Myers Squibb appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Platinol and Adriamycin. Platinol, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian
Mar 01 2006
chlorambucil
Leukeran
Mar 18 1957
cisplatin
Platinol
Dec 19 1978
cisplatin
Platinol
Dec 19 1978
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cisplatin
Platinol
cladribine
Leustatin, 2-CdA
clofarabine
Clolar
indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Platinol therapy. as a single agent for patients with transitional cell bladder cancer which is no longer Bristol-Myers Squibb amenable to local treatments such as surgery and/or radiotherapy. R.W. Johnson Treatment of active Pharmaceutical Research hairy cell leukemia. Institute Accel. Approv. (clinical benefit not established) for the treatment of pediatric patients 1 to 21 years old with relapsed Genzyme or refractory acute lymphoblastic leukemia after at least two prior regimens Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Bristol-Myers Squibb Pharmacia & Upjohn Company Accel. Approv. (clinical benefit not established) Intrathecal therapy of Skye Pharmaceuticals lymphomatous meningitis Bayer Merck Merck provides for the use of Fragmin (dalteparin sodium injection) for extended treatment of
Apr 22 1993
Feb 26 1993
Dec 28 2004
cyclophosphamide cyclophosphamide cyclophosphamide cyclophosphamide cytarabine
Cytoxan, Neosar Cytoxan Injection Cytoxan Injection Cytoxan Tablet Cytosar-U
Nov 16 1959 Nov 16 1959 Apr 29 1987 Apr 29 1987 Jun 17 1969 Apr 01 1999 May 27 1975 Feb 04 1964 Dec 10 1964
cytarabine liposomal
DepoCyt
dacarbazine dactinomycin, actinomycin D dactinomycin, actinomycin D
DTIC-Dome Cosmegen Cosmegan
9 of 39
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dalteparin sodium
Fragmin
darbepoetin alfa
Aranesp
g ( p sodium injection) for extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein Pharmacia & Upjohn thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer. for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in Amgen patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Amgen Treatment of anemia associated with chronic renal failure. Aranesp is indicated for the treatment of anemia in patients with nonmyeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. Chronic myelogenous leukemia First line cytotoxic therapy for advanced, HIV related Kaposis sarcoma. Leukemia/myelogenous /monocytic/erythroid of adults/remission induction in acute lymphocytic leukemia of children and adults. In combination with approved anticancer drugs for induction of Amgen, Inc
May 01 2007
Mar 09 2007
darbepoetin alfa Darbepoetin alfa
Aranesp Aranesp
Apr 10 2007 Sep 17 2001
Darbepoetin alfa
Aranesp
Amgen, Inc
Jul 19 2002
dasatinib
Sprycel
Bristol Myers Squibb
Jun 28 2006 Apr 08 1996
daunorubicin liposomal DanuoXome
Nexstar, Inc.
daunorubicin, daunomycin
Daunorubicin
Bedford Labs
Jan 30 1998
daunorubicin, 10 of 39 daunomycin
Cerubidine
Wyeth Ayerst
Mar 11 1987 1/11/2014 6:58 PM
daunorubicin, daunomycin
Cerubidine
decitabine
Dacogen
denileukin
Ontak
Denileukin diftitox
Ontak
dexrazoxane
Zinecard
11 of 39
In combination with approved anticancer Wyeth Ayerst drugs for induction of remission in adult ALL. for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all FrenchAmerican-British subtypes (refractory anemia, refractory anemia with ringed MGI PHARMA INC sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Seragen Accel. Approv. (clinical benefit not established) treatment of patients with persistent or recurrent cutaneous Seragen, Inc T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor Accel. Approv. (clinical benefit subsequently established) Prevention Pharmacia & Upjohn of cardiomyopathy Company associated with doxorubicin administration Conversion to regular approval for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have Pharmacia & Upjohn
Mar 11 1987
May 05 2006
Feb 05 1999
May 26 1995
1/11/2014 6:58 PM Oct 31
dexrazoxane
Zinecard
docetaxel
Taxotere
docetaxel
Taxotere
docetaxel
Taxotere
docetaxel
Taxotere
12 of 39
administration in women with metastatic breast Pharmacia & Upjohn cancer who have received a cumulative Company doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. It is not recommended for use with the initiation of doxorubicin therapy. Accel. Approv. (clinical benefit subsequently established) Treatment of patients with locally advanced or metastatic breast cancer who have Aventis Pharmaceutical progressed during anthracycline-based therapy or have relapsed during anthracycline-based adjuvant therapy. Conversion to regular approval - treatment of locally advanced or metastatic breast cancer which has progressed Aventis Pharmaceutical during anthracycline-based treatment or relapsed during anthracycline-based adjuvant therapy. For locally advanced or metastatic non-small cell lung cancer after failure Aventis Pharmaceutical of prior platinum-based chemotherapy. for use in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this Aventis Pharmaceutical condition cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell
Oct 31 2002
May 14 1996
Jun 22 1998
Dec 23 1999
Nov 27 2002
1/11/2014 6:58 PM
docetaxel
Taxotere
docetaxel
Taxotere
docetaxel
Taxotere
doxorubicin
Adriamycin PFS
doxorubicin doxorubicin
Adriamycin, Rubex Adriamycin PFS Injectionintravenous injection
with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. For use in combination with prednisone as a treatment for patients with androgen Aventis Pharmaceutical independent (hormone refractory) metastatic prostate cancer For use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment Aventis Pharmaceutical of patients with operable nodepositive breast cancer for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, Sanofi Aventis locally advanced squamous cell carcinoma of the head and neck. For use in combination with cyclophosphamide as a component of adjuvant therapy in patients with evidence Pharmacia of axillary node tumor involvement following resection of primary breast cancer Pharmacia & Upjohn Company Antibiotic, antitumor agent. Pharmacia & Upjohn Company
May 19 2004
Aug 18 2004
Oct 17 2006
May 08 2003
Aug 07 1974 Dec 23 1987
doxorubicin liposomal Doxil
13 of 39
Conversion to regular approval for treatment of patients with ovarian cancer whose disease Alza has progressed or recurred after platinum-based chemotherapy Accel. Approv. (clinical benefit not established)
Jan 28 2005
1/11/2014 6:58 PM
Accel. Approv. (clinical benefit not established) Treatment of AIDS-related Kaposis sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. Accel. Approv. (clinical benefit not established) Treatment of metastatic carcinoma of the ovary in patient with disease that is refractory to both paclitaxel and platinum based regimens
Sequus Pharmaceuticals, Inc.
Nov 17 1995
Sequus Pharmaceuticals, Inc.
Jun 28 1999
DROMOSTANOLONE DROMOSTANOLONE PROPIONATE DROMOSTANOLONE MASTERONE PROPIONATE INJECTION eculizumab Soliris for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma. A component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. is indicated for the treatment of anemia related to therapy with
Eli Lilly SYNTEX
Oct 26 1961 Oct 08 1964 Mar 16 2007
Alexion
Elliotts B Solution
Elliotts B Solution
Orphan Medical, Inc
Sep 27 1996
epirubicin
Ellence
Pharmacia & Upjohn Company
Sep 15 1999
epirubicin hcl
epirubicin hcl
Mayne
Sep 15 2006
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1/11/2014 6:58 PM
epoetin alfa
Epogen/Procrit
Epoetin alfa
epogen
15 of 39
is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. EPOGEN is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to Amgen decrease the need for transfusions in these patients. EPOGEN is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately. EPOGENB is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. EPOGEND is indicated to decrease the need for transfusions in patients who will be receiving Amgen, Inc concomitant chemotherapy for a minimum of 2 months. EPOGENB is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately. EPOGENB is indicated for the reatment of anemia related to
Mar 09 2007
Jul 26 1999
1/11/2014 6:58 PM
Epoetin alfa
epogen
Epoetin alfa
epogen
Epoetin alfa
epogen
erlotinib
Tarceva
erlotinib
Tarceva
16 of 39
EPOGENB is indicated for the reatment of anemia related to therapy with zidovudine in HIV- infected patients. EPOGENB is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEND is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately. EPOGENB is indicated for the treatment of anemic patients (hemoglobin > 10 to _< 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. EPOGEN is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. For treatment of locally advanced or metastatic Non Small-Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen For use in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer
Amgen, Inc
Jul 26 1999
Amgen, Inc
Jul 26 1999
Amgen, Inch
Jul 26 1999
OSI
Nov 18 2004
OSI
Nov 02 2005
1/11/2014 6:58 PM
estramustine
Emcyt
etoposide phosphate
Etopophos
etoposide phosphate
Etopophos
etoposide phosphate
Etopophos
etoposide, VP-16
Vepesid
etoposide, VP-16
VePesid
etoposide, VP-16
Vepesid
exemestane
Aromasin
17 of 39
, or metastatic pancreatic cancer palliation of prostate Pharmacia & Upjohn cancer Company Management of refractory testicular tumors, in combination Bristol-Myers Squibb with other approved chemotherapeutic agents. Management of small cell lung cancer, first-line, in combination Bristol-Myers Squibb with other approved chemotherapeutic agents. Management of refractory testicular Bristol-Myers Squibb tumors and small cell lung cancer. Refractory testicular tumors-in combination therapy with other approved chemotherapeutic agents in patients with Bristol-Myers Squibb refractory testicular tumors who have already received appropriate surgical, chemotherapeutic and radiotherapeutic therapy. In combination with other approved chemotherapeutic agents Bristol-Myers Squibb as first line treatment in patients with small cell lung cancer. In combination with other approved chemotherapeutic agents Bristol-Myers Squibb as first line treatment in patients with small cell lung cancer. For adjuvant treatment of postmenopausal women with estrogenreceptor positive early breast cancer who have received two to three years of tamoxifen and Pharmacia are switched to AROMASIN for
Dec 24 1981
May 17 1996
May 17 1996
Feb 27 1998
Nov 10 1983
Dec 30 1986
Dec 30 1986
Oct 05 2005
1/11/2014 6:58 PM
exemestane
Aromasin
exemestane
Aromasin
fentanyl citrate
Fentora
Filgrastim
Neupogen
Filgrastim
Neupogen
Filgrastim
Neupogen
Filgrastim
Neupogen
years of tamoxifen and Pharmacia are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy Treatment of advance breast cancer in postmenopausal women Pharmacia & Upjohn whose disease has Company progressed following tamoxifen therapy. for the management of breakthrough pain in patients with cancer who are already receiving Cephalon and who are tolerant to opioid therapy for their underlying persistent cancer pain. Decrease incidence of infection in patients with Amgen, Inc nonmyeloid malignancies NEUPOGEN is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving Amgen, Inc myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. NEUPOGEN is indicated for reducing the time to neutrophil recovery and the Amgen, Inc duration of fever, following induction or consolidation hemotherapy treatment of adults with AML. NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, eg, febrile neutropenia, in Amgen, Inc patients with
2005
Oct 21 1999
Sep 25 2006
Feb 20 1991
Apr 02 1998
Apr 02 1998
18 of 39
Apr 02 1998 1/11/2014 6:58 PM
Filgrastim
Neupogen
febrile neutropenia, in patients with Amgen, Inc nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. Roche Palliative treatment of patients with B-cell lymphocytic leukemia (CLL) who have not responded or have Berlex Laboratories Inc. progressed during treatment with at least one standard alkylating agent containing regimen. prolong survival in combination with ICN Puerto Rico leucovorin the treatment of hormone receptorpositive metastatic breast cancer in IPR postmenopausal women with disease progression following antiestrogen therapy Accel. Approv. (clinical benefit not established ) as monotherapy for the treatment of patients with locally advanced or AstraZenca metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies Treatment of patients with locally advanced (nonresectable stage II or III) or metastatic (stage IV) adenocarcinoma of the Eli Lilly pancreas. Indicated for first-line treatment and for patients previously treated with a 5-fluorouracil-containing regimen. For use in combination
Apr 02 1998
floxuridine (intraarterial)
FUDR
Dec 18 1970
fludarabine
Fludara
Apr 18 1991
fluorouracil, 5-FU
Adrucil
Apr 25 1962
fulvestrant
Faslodex
Apr 25 2002
gefitinib
Iressa
May 05 2003
gemcitabine
Gemzar
May 15 1996
19 of 39
1/11/2014 6:58 PM
g regimen. For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage Eli Lilly IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. Ovarian cancer Lilly
gemcitabine
Gemzar
Aug 25 1998
gemcitabine hcl
Gemzar
Jul 14 2006
gemicitabine
Gemzar
gemtuzumab ozogamicin
Mylotarg
goserelin acetate
Zoladex
goserelin acetate
Zoladex Implant
histrelin acetate hydroxyurea hydroxyurea
Histrelin implant Hydrea Hydrea
For use in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior Lilly anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated Accel. Approv. (clinical benefit not established) Treatment of CD33 positive acute myeloid leukemia in patients in Wyeth Ayerst first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. AstraZeneca Pharmaceuticals Palliative treatment of advanced breast cancer AstraZeneca Pharmaceuticals in pre- and perimenopausal women. For the palliative treatment of advanced Valera prostate cancer Bristol-Myers Squibb Decrease need for transfusions in sickle cell Bristol-Myers Squibb anemia Accel. Approv. (clinical benefit not established) treatment of patients with relapsed or refractory low-grade, follicular, or transformed IDEC Pharmaceuticals
May 19 2004
May 17 2000
Dec 18 1995 Dec 18 1995 Oct 12 2004 Dec 07 1967 Feb 25 1998
20 of 39
Ibritumomab Tiuxetan Zevalin
Feb 19
1/11/2014 6:58 PM
Ibritumomab Tiuxetan Zevalin
idarubicin
Idamycin
idarubicin
Idamycin
ifosfamide
IFEX
imatinib mesylate
Gleevec
imatinib mesylate
Gleevec
Imatinib mesylate
Gleevec
imatinib mesylate
Gleevec
21 of 39
p refractory low-grade, follicular, or transformed IDEC Pharmaceuticals B-cell non-Hodgkins Corp lymphoma, including patients with Rituximab refractory follicular non-Hodgkins lymphoma. For use in combination with other approved antileukemic drugs for Adria Laboratories the treatment of acute myeloid leukemia (AML) in adults. In combination with other approved antileukemic drugs for Pharmacia & Upjohn the treatment of acute Company non-lymphocytic leukemia in adults. Third line chemotherapy of germ cell testicular cancer when used in Bristol-Myers Squibb combination with certain other approved antineoplastic agents. Accel. Approv. (clinical benefit not established) Novartis Initial therapy of chronic myelogenous leukemia Accel. Approv. (clinical benefit not established) metastatic or Novartis unresectable malignant gastrointestinal stromal tumors Accel. Approv. (clinical benefit not established) Treatment of patients with Kit (CD117) Novartis positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). Accel. Approv. (clinical benefit not established) Initial treatment of Novartis newly diagnosed Ph+ chronic myelogenous leukemia (CML). Accel. Approv. (clinical benefit not established) for treatment of newly
Feb 19 2002
Sep 27 1990
Feb 17 1997
Dec 30 1988
May 10 2001
Feb 01 2002
Feb 01 2002
Dec 20 2002
1/11/2014 6:58 PM
imatinib mesylate
Gleevec
imatinib mesylate
Gleevec
22 of 39
Accel. Approv. (clinical benefit not established) for treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase. Follow-up is limited. Gleevec is also indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of Novartis interferon-alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in diseaserelated symptoms or increased survival in patients with CML blast crisis, accelerated phase or chronic phase after failure of alpha interferon. Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) Accel. Approv. (clinical benefit not established) Treatment of pediatric patients with Ph+ chronic phase CML Novartis whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. Conversion to regular approval for treatment of patients with Philadelphia chromosome positive
Apr 18 2003
May 20 2003
1/11/2014 6:58 PM Dec 08
imatinib mesylate
Gleevec
imatinib mesylate
Gleevec
imatinib mesylate interferon alfa 2a
Gleevec Roferon A
interferon alfa 2a
Roferon A
p Philadelphia chromosome positive chronic myeloid Novartis leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy for the treatment of pediatric patients with newly diagnosed Philadelphia Novartis chromosome positive chronic myelogenous leukemia (Ph+ CML). single agent for the treatment of multiple Novartis indications Treatment of patients Roche with hairy cell leukemia Chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia (CML) Roche patients who are minimally pretreated (within 1 year of diagnosis) Hoffmann-La Roche Inc Interferon alfa-2b, recombinant for Injection is indicated for Schering Corp the treatment of patients 18 years of age or older with hairy cell leukemia. Interferon alfa-2b, recombinant for Injection is indicated for intralesional treatment of selected patients 18 Schering Corp years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas. Interferon alfa-2b, recombinant for injection is indicated for the treatment of selected patients 18 years of age or older with
Dec 08 2003
Sep 27 2006
Oct 19 2006 Jun 04 1986
Oct 19 1995
Interferon alfa-2a
Roferon-A
Nov 01 1996
Interferon alfa-2b
Intron A
Jun 04 1986
Interferon alfa-2b
Intron A
Jun 06 1988
23 of 39
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Interferon alfa-2b
Intron A
Interferon alfa-2b
Intron A
Interferon alfa-2b
Intron A
the treatment of selected patients 18 years of age or older with AIDS-related Kaposis Sarcoma. The likelihood of response to INTRON Schering Corp A therapy is greater in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immune system as indicated by total CD4 count. Interferon alfa-2b, recombinant for injection is indicated as adjuvant to surgical treatment in patients 18 years of age or older Schering Corp with malignant melanoma who are free of disease but at high risk for systemic recurrence within 56 days of surgery. Interferon alfa-2b, recombinant for Injection is indicated for the initial treatment of clinically aggressive follicular non-Hodgkins Schering Corp Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. Schering Corp Accel. Approv. (clinical benefit subsequently established) Treatment of patients with metastatic carcinoma of Pharmacia & Upjohn Company the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. Conversion to regular approval - treatment of metastatic carcinoma of
Nov 21 1988
Dec 05 1995
Nov 06 1997
Interferon alfa-2b
Intron A Intron A
Jun 21 2002
irinotecan
Camptosar
Jun 14 1996
24 of 39
1/11/2014 6:58 PM
irinotecan
Camptosar
irinotecan
Camptosar
lapatinib ditosylate
Tykerb
Conversion to regular approval - treatment of metastatic carcinoma of the colon or rectum Pharmacia & Upjohn whose disease has Company recurred or progressed following 5-FU-based therapy. For first line treatment n combination with Pharmacia & Upjohn 5-FU/leucovorin of Company metastatic carcinoma of the colon or rectum. for use in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors SmithKline Beecham overexpress HER2 (ErbB2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. SmithKline Beecham Multiple myeloma Celegene
Oct 22 1998
Apr 20 2000
Mar 13 2007
lapatinib ditosylate lenalidomide
Tykerb Revlimid
Apr 27 2007 Jun 29 2006
lenalidomide
Revlimid
letrozole
Femara
letrozole
Femara
for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic Celgene syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities Treatment of advanced breast cancer in Novartis postmenopausal women. First-line treatment of postmenopausal women with hormone receptor positive or hormone Novartis receptor unknown locally advanced or metastatic breast cancer. Novartis Accel. Approv. (clinical
Dec 27 2005
Jul 25 1997
Jan 10 2001
letrozole
Femara
Jan 17 2003
25 of 39
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letrozole
Femara
Novartis Accel. Approv. (clinical benefit not established) for the extended adjuvant treatment of early breast cancer in Novartis postmenopausal women who have received five years of adjuvant tamoxifen therapy. Leucovorin calcium is indicated fro use in combination with 5-fluorouracil to prolong Immunex Corporation survival in the palliative treatment of patients with advanced colorectal cancer. Immunex Corporation Immunex Corporation Immunex Corporation In combination with fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. palliative treatment of advanced prostate cancer. Adjuvant treatment in combination with 5-fluorouracil after surgical resection in patients with Dukes Stage C colon cancer.
Jan 17 2003
letrozole
Femara
Oct 29 2004
leucovorin
Wellcovorin, Leucovorin
Jun 20 1952
leucovorin leucovorin leucovorin
Leucovorin Leucovorin Leucovorin
Jan 30 1987 Jan 30 1987 Aug 31 1988
leucovorin
Leucovorin
Lederle Laboratories
Dec 12 1991
Leuprolide Acetate
Eligard
QLT USA
Jan 23 2002
levamisole
Ergamisol
Janssen Research Foundation
Jun 18 1990
lomustine, CCNU meclorethamine, nitrogen mustard megestrol acetate melphalan, L-PAM
CeeBU Mustargen Megace Alkeran
Bristol-Myers Squibb Merck Bristol-Myers Squibb GlaxoSmithKline Systemic administration for palliative treatment of patients with multiple GlaxoSmithKline myeloma for whom oral therapy is not
Aug 04 1976 Mar 15 1949 Aug 18 1971 Jan 17 1964
melphalan, L-PAM
Alkeran
Nov 18 1992
26 of 39
1/11/2014 6:58 PM
melphalan, L-PAM
Alkeran
myeloma for whom oral therapy is not appropriate.
GlaxoSmithKline
1992
mercaptopurine, 6-MP Purinethol mesna Mesnex
GlaxoSmithKline Prevention of ifosfamide-induced Asta Medica hemorrhagic cystitis Reducing the incidence of ifosfamide-induced Baxter hemorrhagic cystitis Lederle Laboratories Lederle Laboratories Lederle Laboratories Lederle Laboratories osteosarcoma Lederle Laboratories Lederle Laboratories For the use of UVADEX with the UVAR Photopheresis System in the palliative treatment of the skin Therakos manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. Bristol-Myers Squibb therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations Supergen with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Bristol-Myers Squibb For use in combination with corticosteroids as initial chemotherapy for the treatment of patients Immunex Corporation with pain related to advanced hormonerefractory prostate
Sep 11 1953 Dec 30 1988 Mar 21 2002 Dec 07 1953 Aug 10 1959 Nov 01 1971 Nov 01 1971 Apr 07 1988 Oct 31 1988
mesna methotrexate methotrexate methotrexate methotrexate methotrexate methotrexate
Mesnex tabs Methotrexate Methotrexate Methotrexate Methotrexate Methotrexate Methotrexate
methoxsalen
Uvadex
Feb 25 1999
mitomycin C
Mutamycin
May 28 1974
mitomycin C
Mitozytrex
Nov 14 2002
mitotane
Lysodren
Jul 08 1970
mitoxantrone
Novantrone
Nov 13 1996
27 of 39
1/11/2014 6:58 PM
mitoxantrone
Novantrone
p with pain related to advanced hormonerefractory prostate cancer. For use with other approved drugs in the initial therapy for acute Lederle Laboratories nonlymphocytic leukemia (ANLL) in adults. Organon Accel. Approv. (clinical benefit not established) for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic GlaxoSmithKline lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens Boehringer Ingelheim Pharma KG (formerly Dr. Karl Thomae GmbH) Prevention of severe thrombocytopenia following Genetics Institute, Inc myelosuppressive chemotherapy Genetics Institute, Inc Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following Genetics Institute, Inc myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. warnings regarding ophthalmologic and ventricular arrhythmias Wyeth adverse events have been added to the
1996
Dec 23 1987
nandrolone phenpropionate
Durabolin-50
Oct 30 1959
nelarabine
Arranon
Oct 28 2005
Nofetumomab
Verluma
Aug 20 1996
Oprelvekin
Neumega
Nov 25 1997 Sep 18 2002
Oprelvekin
Neumega
Oprelvekin
Neumega
Sep 18 2002
oprelvekin
Neumega
Sep 13 2006
28 of 39
1/11/2014 6:58 PM
oprelvekin
Neumega
oxaliplatin
Eloxatin
oxaliplatin
Eloxatin
oxaliplatin
Eloxatin
paclitaxel
Abraxane
paclitaxel
Paxene
29 of 39
y adverse events have Wyeth been added to the oprelvekin (Neumega) label Accel. Approv. (clinical benefit not established) in combination with infusional 5-FU/LV, is indicated for the treatment of patients with metastatic carcinoma of the colon Sanofi Synthelabo or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan. Conversion to regular approval for use in combination with infusional 5-Fluorouracil (5-FU) and Leucovorin Sanofi Synthelabo (LV) for the treatment of patients previously untreated for advanced colorectal cancer for use in combination with infusional 5-FU/LV, for the adjuvant treatment of stage III Sanofi Synthelabo colon cancer patients who have undergone complete resection of the primary tumor for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months Abraxis of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. treatment of advanced AIDS-related Kaposis Baker Norton sarcoma after failure of Pharmaceuticals, Inc first line or subsequent
Sep 13 2006
Aug 09 2002
Jan 09 2004
Nov 04 2004
Feb 15 2007
Dec 24 1997
1/11/2014 6:58 PM
paclitaxel
Paxene
paclitaxel
Taxol
paclitaxel
Taxol
paclitaxel
Taxol
paclitaxel
Taxol
paclitaxel
Taxol
paclitaxel
Taxol
paclitaxel
Taxol
30 of 39
paclitaxel
Taxol
S e ed pos s Baker Norton sarcoma after failure of Pharmaceuticals, Inc first line or subsequent systemic chemotherapy Treatment of patients with metastatic carcinoma of the ovary Bristol-Myers Squibb after failure of first-line or subsequent chemotherapy. Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant Bristol-Myers Squibb chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. New dosing regimen for patients who have failed initial or subsequent Bristol-Myers Squibb chemotherapy for metastatic carcinoma of the ovary second line therapy for AIDS related Kaposis Bristol-Myers Squibb sarcoma. For first-line therapy for the treatment of advanced carcinoma of Bristol-Myers Squibb the ovary in combination with cisplatin. for use in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who Bristol-Myers Squibb are not candidates for potentially curative surgery and/or radiation therapy. For the adjuvant treatment of node-positive breast Bristol-Myers Squibb cancer administered sequentially to standard doxorubicin-containing combination therapy. First line ovarian cancer Bristol-Myers Squibb with 3 hour infusion.
Dec 24 1997
Dec 29 1992
Apr 13 1994
Jun 22 1994
Aug 04 1997
Apr 09 1998
Jun 30 1998
Oct 25 1999
Jun 20 1/11/2014 6:58 PM 2000
paclitaxel
Taxol
paclitaxel Abraxane protein-bound particles
palifermin
Kepivance
pamidronate
Aredia
panitumumab
Vectibix
pegademase
Adagen (Pegademase Bovine)
pegaspargase
Oncaspar
pegaspargase
Oncaspar
Pegfilgrastim
Neulasta
31 of 39
combination therapy. First line ovarian cancer Bristol-Myers Squibb with 3 hour infusion. For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months AM Bioscience of adjuvant chemotherapy. Prior therapy should have included an anthracyline unless clinically contraindicated Decrease the incidence and duration of severe oral mucositis in patients with hematologic Amgen malignancies receiving myelotoxic therapy requiring hematopoetic stem cell support Treatment of osteolytic bone metastases of breast cancer in Novartis conjunction with standard antineoplastic therapy. to treat metastatic Amgen colorectal carcinoma Enzyme replacement therapy for patients with severe combined Enzon immunodeficiency asa result of adenosine deaminase deficiency. Acute lymphoblastic Enzon leukemia Acute lymphocytic leukemia in Enzon, Inc L-asparaginase hypersensitive patients Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving Amgen, Inc myelosuppressive anti-cancer drugs associated with a clinically significant
Jun 20 2000
Jan 07 2005
Dec 15 2004
Sep 22 1998
Sep 27 2006
Mar 21 1990
Jul 24 2006 Feb 01 1994
Jan 31 2002
1/11/2014 6:58 PM
Peginterferon alfa-2b
PegIntron
pemetrexed disodium
Alimta
pemetrexed disodium
Alimta
pentostatin
Nipent
pentostatin
Nipent
anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. trade name from Schering PEG-Intron to PegIntron For use in the treatment of patients with malignant pleural mesothelioma whose Lilly disease is either unresectable or who are otherwise not candidates for curative surgery Accel. Approv. (clinical benefit not established) as a single agent for the treatment of patients Lilly with locally advanced or metastatic non-small lung cancer after prior chemotherapy Single agent treatment for adult patients with Parke-Davis alpha interferon Pharmaceutical Co. refractory hairy cell leukemia. Single-agent treatment for untreated hairy cell leukemia patients with active disease as defined by clinically significant Parke-Davis Pharmaceutical Co. anemia, neutropenia, thrombocytopenia, or disease-related symptoms. (Supplement for front -line therapy.) Abbott Labs Pfizer Labs
Dec 22 2006
Feb 04 2004
Aug 19 2004
Oct 11 1991
Sep 29 1993
pipobroman plicamycin, mithramycin
Vercyte Mithracin
Jul 01 1966 May 05 1970
porfimer sodium
Photofrin
porfimer sodium
Photofrin
32 of 39
For the ablation of high-grade dysplasia in Aug 01 Axcan Scandipharm Barretts esophagus 2003 patients who do not undergo esophagectomy For use in photodynamic therapy (PDT) for palliation of patients with completely obstructing esophageal Dec 27 cancer, or patients with QLT Phototherapeutics Inc. 1995 partially obstructing
1/11/2014 6:58 PM
porfimer sodium
Photofrin
porfimer sodium
Photofrin
porfimer sodium
Photofrin
procarbazine quinacrine
Matulane Atabrine
Rasburicase
Elitek
rituximab
Rituxan
rituximab
Rituxan
33 of 39
g p g Dec 27 cancer, or patients with QLT Phototherapeutics Inc. 1995 partially obstructing esophageal cancer who cannot be satisfactorily treated with ND-YAG laser therapy. For use in photodynamic therapy for treatment of microinvasive endobronchial nonsmall Jan 09 QLT Phototherapeutics Inc. cell lung cancer in 1998 patients for whom surgery and radiotherapy are not indicated. For use in photodynamic therapy (PDT) for reduction of obstruction and palliation of symptoms in patients Dec 22 QLT Phototherapeutics Inc. with completely or 1998 partially obstructing endobroncial nonsmall cell lung cancer (NSCLC). Jul 22 Sigma Tau Pharms 1969 Dec 07 Abbott Labs 1964 ELITEK is indicated for the initial management of plasma uric acid levels in pediatric patients with leukemia, Jul 12 lymphoma, and solid Sanofi-Synthelabo, Inc 2002 tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. for the first-line treatment of patients with low grade or Sep 29 Genentech follicular, CD20-positive 2006 B-cell non-Hodgkins lymphoma. for the first-line treatment of patients Sep 29 with low grade or Genentech 2006 follicular, CD20-positive B-cell non-Hodgkins lymphoma. Treatment of patients 1/11/2014 6:58 PM with relapsed or
Rituximab
Rituxan
Rituximab
Rituxan
sargramostim
Leukine
lymphoma. Treatment of patients with relapsed or refractory low-grade or Genentech, Inc follicular B-cell non-Hodgkins lymphoma non-Hodgkins Genentech, Inc lymphoma Acceleration of myeloid recovery following autologous bone marrow transplant in patients Berlex with non-Hodgkins lymphoma, acute lymphocytic leukemia, or Hodgkins disease Immunex Corp For the treatment of patients with advanced renal cell carcinoma Antineoplastic agent. Bayer Pharmacia & Upjohn Company
Nov 26 1997
Feb 10 2006
Mar 05 1991
Sargramostim sorafenib streptozocin
Prokine Nexavar Zanosar
Nov 07 1996 Dec 20 2005 May 07 1982
sunitinib
Sutent
sunitinib maleate
Sutent
sunitinib maleate
Sutent
34 of 39
for the treatment of gastrointestinal stromal tumor after disease progression on or CP Pharmaceuticals intolerance to imatinib mesylate; for the treatment of advanced renal cell carcinoma. treatment of gastrointestinal stromal tumor after disease Pfizer progression on or intolerance to imatinib mesylate Accel. Approv. (clinical benefit not established) for the treatment of advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates Pfizer and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in diseaserelated symptoms in
Feb 02 2007
Jan 26 2006
Jan 26 2006
1/11/2014 6:58 PM
talc
Sclerosol
tamoxifen
Nolvadex
tamoxifen
Nolvadex
tamoxifen
Nolvadex
tamoxifen
Nolvadex
tamoxifen
Nolvadex
tamoxifen
Nolvadex
tamoxifen
Nolvadex
tamoxifen
Nolvadex
temozolomide
Temodar
35 of 39
increased survival or improvement in diseaserelated symptoms in renal cell carcinoma. For the prevention of the recurrence of malignant Bryan pleural effusion in symptomatic patients. AstraZeneca Pharmaceuticals As a single agent to delay breast cancer recurrence following total mastectomy and AstraZeneca axillary dissection in Pharmaceuticals postmenopausal women with breast cancer (T1-3, N1, M0) For use in premenopausal women with metastatic breast AstraZeneca cancer as an alternative Pharmaceuticals to oophorectomy or ovarian irradiation For use in women with axillary node-negative AstraZeneca breast cancer adjuvant Pharmaceuticals therapy. Metastatic breast cancer AstraZeneca in men. Pharmaceuticals Equal bioavailability of a 20 mg Nolvadex tablet AstraZeneca taken once a day to a 10 Pharmaceuticals mg Nolvadex tablet taken twice a day. to reduce the incidence of breast cancer in AstraZeneca women at high risk for Pharmaceuticals breast cancer In women with DCIS, following breast surgery and radiation, Nolvadex AstraZeneca is indicated to reduce Pharmaceuticals the risk of invasive breast cancer. Accel. Approv. (clinical benefit not established) Treatment of adult patients with refractory anaplastic astrocytoma, Schering i.e., patients at first relapse with disease progression on a nitrosourea and
Dec 24 1997 Dec 30 1977
Dec 03 1986
Mar 16 1989
Jun 21 1990 Apr 01 1993 Mar 21 1994
Oct 29 1998
Jun 29 2000
Aug 11 1999
1/11/2014 6:58 PM
temozolomide
Temodar
teniposide, VM-26
Vumon
relapse with disease progression on a nitrosourea and procarbazine containing regimen Conversion to regular approval for the treatment of patients with newly diagnosed Schering high grade gliomas concomitantly with radiotherapy and then as adjuvant treatment In combination with other approved anticancer agents for induction therapy in Bristol-Myers Squibb patients with refractory childhood acute lymphoblastic leukemia (all). Bristol-Myers Squibb Bristol-Myers Squibb Multiple myeloma Celgene GlaxoSmithKline Immunex Corporation Immunex Corporation Lederle Laboratories Treatment of patients with metastatic carcinoma of the ovary GlaxoSmithKline after failure of initial or subsequent chemotherapy. Treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as GlaxoSmithKline disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least
Mar 15 2005
Jul 14 1992
testolactone testolactone thalidomide thioguanine, 6-TG thiotepa thiotepa thiotepa
Teslac Teslac Thalomid Thioguanine Thioplex Thioplex Thioplex
Jun 03 1969 May 27 1970 May 26 2006 Jan 18 1966 Mar 09 1959 Dec 22 1994 Aug 15 1990
topotecan
Hycamtin
May 28 1996
topotecan
Hycamtin
Nov 30 1998
36 of 39
1/11/2014 6:58 PM
subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy topotecan hcl toremifene Hycamtin Fareston Cervical carcinoma GlaxoSmithKline Jun 14 2006 May 29 1997
Tositumomab
Bexxar
Tositumomab/I-131 tositumomab
Bexxar
trastuzumab
Herceptin
Trastuzumab
Herceptin
Trastuzumab
Herceptin
37 of 39
Treatment of advanced breast cancer in Orion Corp. postmenopausal women. Accel. Approv. (clinical benefit not established) Treatment of patients with CD20 positive, follicular, non-Hodgkins lymphoma, with and Corixa Corporation without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy Expand the indication to include patients with relapsed or refractory low grade follicular GlaxoSmithKline transformed CD20-positive non-Hodgkins lymphoma who have not received rituximab Early Stage Breast Cancer After Primary Genentech Therapy HERCEPTIN as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 Genentech, Inc protein and who have received one or more chemotherapy regimens for their metastatic disease. Herceptin in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors Genentech, Inc overexpress the HER-2 protein and had not received chemotherapy for their metastatic
Jun 27 2003
Dec 22 2004
Nov 16 2006
Sep 25 1998
Feb 09 2000
1/11/2014 6:58 PM
protein and had not received chemotherapy for their metastatic disease Trastuzumab Trastuzumab Herceptin Herceptin Genentech, Inc Genentech, Inc Induction of remission in patients with acute promyelocytic leukemia (APL) who are refractory to or unable Roche to tolerate anthracycline based cytotoxic chemotherapeutic regimens. Roberts Labs For intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom Anthra > Medeva immediate cystectomy would be associated with unacceptable morbidity or mortality. Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly Single agent or in combination with cisplatin for the first-line treatment of ambulatory GlaxoSmithKline patients with unresectable, advanced non-small cell lung cancer (NSCLC). Navelbine is indicated as Aug 28 2002 Aug 28 2002
tretinoin, ATRA
Vesanoid
Nov 22 1995
Uracil Mustard
Uracil Mustard Capsules
Sep 13 1962
valrubicin
Valstar
Sep 25 1998
vinblastine vincristine vincristine vincristine vincristine vincristine vincristine vincristine
Velban Oncovin Oncovin Oncovin Oncovin Oncovin Oncovin Oncovin
Nov 05 1965 Jul 10 1963 Jul 10 1963 Jul 10 1963 Jul 10 1963 Jul 10 1963 Jul 10 1963 Jul 10 1963
vinorelbine
Navelbine
Dec 23 1994
38 of 39
1/11/2014 6:58 PM
vinorelbine
Navelbine
vorinostat
Zolinza
zoledronate
Zometa
zoledronic acid
Zometa
non-small cell lung cancer (NSCLC). Navelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unreseactable, advanced non-small cell lung cancer (NSCLC). In GlaxoSmithKline patients with Stage IV NSCLC, Navelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Navelbine is indicated in combination with cisplatin. for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in Merck patients with progressive, persistent, or recurrent disease on or following two systemic therapies. the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction Novartis with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy Treatment of hypercalcemia of Novartis malignancy
Nov 05 2002
Oct 06 2006
Feb 22 2002
Aug 20 2001
39 of 39
1/11/2014 6:58 PM

List of Anti-Cancer Drugs Aproved by The FDA - PharmaKnow

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List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.

Drug Trade Name

Jan 09 1998 May 05 1992

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Sep 25 2000 Jan 10 1978

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

BCG Live bevacizumab

TICE BCG Avastin

Aug 21 1998 Jun 20 2006

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Orphan Medical, Inc

busulfan oral calusterone

GlaxoSmithKline Pharmacia & Upjohn Company

Jun 26 1954 Feb 20 1973

Accel. Approv. (clinical

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Mar 03 1/11/2014 6:58 PM

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Mar 07 1977 Feb 25 2003

carmustine with Polifeprosan 20 Implant

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

cyclophosphamide cyclophosphamide cyclophosphamide cyclophosphamide cytarabine

Cytoxan, Neosar Cytoxan Injection Cytoxan Injection Cytoxan Tablet Cytosar-U

dacarbazine dactinomycin, actinomycin D dactinomycin, actinomycin D

DTIC-Dome Cosmegen Cosmegan

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

darbepoetin alfa Darbepoetin alfa

Apr 10 2007 Sep 17 2001

Bristol Myers Squibb

Jun 28 2006 Apr 08 1996

daunorubicin liposomal DanuoXome

Mar 11 1987 1/11/2014 6:58 PM

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

1/11/2014 6:58 PM Oct 31

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Adriamycin, Rubex Adriamycin PFS Injectionintravenous injection

Aug 07 1974 Dec 23 1987

doxorubicin liposomal Doxil

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

doxorubicin liposomal Doxil

doxorubicin liposomal Doxil

Sequus Pharmaceuticals, Inc.

Sequus Pharmaceuticals, Inc.

Eli Lilly SYNTEX

Oct 26 1961 Oct 08 1964 Mar 16 2007

Orphan Medical, Inc

Pharmacia & Upjohn Company

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Apr 02 1998 1/11/2014 6:58 PM

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

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histrelin acetate hydroxyurea hydroxyurea

Histrelin implant Hydrea Hydrea

Ibritumomab Tiuxetan Zevalin

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com

Ibritumomab Tiuxetan Zevalin

List of Anti-Cancer Drugs Aproved By the FDA | PharmaKnow.com