Bloomberg Businessweek

The Problem With A Quick ‘Yes’ to Drugs

• A decade after it approved Makena, the FDA is reevaluating the premature-birth drug

One in 10 babies in the U.S. is born premature, with elevated rates of disability and death. For almost a decade, a drug called Makena has been used to reduce the risk of further instances of early delivery for women who’ve previously given birth prematurely. The medicine, approved in 2011 under the Food and Drug Administration’s accelerated process, contributed more than $300 million of annual sales for its manufacturer, Amag Pharmaceuticals Inc.

New research calling into question how well the drug works is now prompting

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