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2048 Federal Register / Vol. 71, No.

8 / Thursday, January 12, 2006 / Notices

Schering has not discontinued agency; however, FDA recommends that SUMMARY: The Food and Drug
manufacture of Celestone Soluspan in considering whether to file an ANDA Administration (FDA) is providing
injection; however, as a result of a May for this drug product, future applicants notice of a memorandum of
2002 consent decree addressing be advised that the RLD may not be understanding (MOU) between the
manufacturing concerns, Schering’s commercially available because it is United States Food and Drug
manufacture and distribution of being made available in certain Administration, Department of Health
Celestone Soluspan injection has been instances of medical necessity only. An and Human Services and the Australian
limited to providing the drug for certain ANDA applicant who is unable to Pesticides and Veterinary Medicines
medically necessary uses under a obtain Celestone Soluspan injection for Authority (APVMA), Australia. This
limited distribution program. Celestone bioequivalence testing must contact the MOU is intended to establish an
Soluspan injection is being distributed Office of Generic Drugs for a information-sharing arrangement
as medically necessary for the following determination of what showing is between APVMA and FDA. The
uses: (1) Neonatal use (fetal lung necessary to satisfy the requirements of Participants intend to strengthen the
maturation), (2) epidural route for the section 505(j)(2)(A)(iv) of the act. If an exchange of knowledge and expertise to
management of pain due to ANDA is approved without a showing enhance the efficiency and effectiveness
radiculopathy in patients not responsive of bioequivalence, the approved product of their respective roles. This MOU
to systemic drug therapy and other will not be granted an AB rating in the focuses on cooperation in relations to
adjunctive therapies, and (3) intra- Orange Book. Future applicants for the operational aspects of animal drug
articular and soft tissue injections for betamethasone sodium phosphate and regulation and is not intended to cover
synovitis of osteoarthritis, acute gouty betamethasone acetate injection are broader government regulatory policy or
arthritis, nonspecific tenosynovitis, and advised that if the RLD product becomes to cover areas not falling under the
acute and subacute bursitis. Information commercially available prior to ANDA common jurisdictional purview of the
regarding the current distribution for approval, the ANDA applicant will need Participants.
Celestone Soluspan injection by to show bioequivalence to the RLD
Schering can be found on FDA’s Drug product. DATES:The agreement became effective
Shortage Web site: http://www.fda.gov/ October 20, 2005.
Dated: January 4, 2006.
cder/drug/shortages/celestone.htm. Jeffrey Shuren, FOR FURTHER INFORMATION CONTACT:
FDA has reviewed its records and, Matthew E. Eckel, Office of
Assistant Commissioner for Policy.
under § 314.161, has determined that International Programs, Food and Drug
Celestone Soluspan (betamethasone [FR Doc. E6–178 Filed 1–11–06; 8:45 am]
Administration, 5600 Fishers Lane
sodium phosphate and betamethasone BILLING CODE 4160–01–S
(HFG–1), Rockville MD, 20857, 301–
acetate) injection and Celestone 827–4480, FAX 301–480–0716.
(betamethasone sodium phosphate)
injection were not withdrawn from sale
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In
for reasons of safety or effectiveness.
HUMAN SERVICES accordance with 21 CFR 20.108(c),
Accordingly, the agency will continue which states that all written agreements
Food and Drug Administration and MOUs between FDA and others
to list betamethasone sodium phosphate
in the ‘‘Discontinued Drug Product List’’ [FDA–225–05–8006] shall be published in the Federal
section of the Orange Book. The Register, the agency is publishing notice
‘‘Discontinued Drug Product List’’ Memorandum of Understanding of this MOU.
delineates, among other items, drug Between the United States Food and Dated: January 4, 2006.
products that have been discontinued Drug Administration Department of Jeffrey Shuren,
from marketing for reasons other than Health and Human Services and the Assistant Commissioner for Policy.
safety or effectiveness. ANDAs that refer Australian Pesticides and Veterinary
BILLING CODE 4160–01–S
to betamethasone sodium phosphate Medicines Authority, Australia
may be approved by the agency. ANDAs AGENCY: Food and Drug Administration,
that refer to betamethasone sodium HHS.
phosphate and betamethasone acetate
ACTION: Notice.
injection also may be approved by the
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[FR Doc. 06–251 Filed 1–11–06; 8:45 am]


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