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Duramed to Appeal FDA Rejection of Drug

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(Bloomberg News)

Duramed Pharmaceuticals Inc. said it will appeal a Food and Drug Administration decision keeping its generic version of a blockbuster estrogen drug off the market. The company’s appeal is based in part on a report from Health and Human Services investigators that raised questions about the formulation of the brand-name drug, sold as Premarin by American Home Products Corp. Duramed shares plummeted last month after the agency ruled that it couldn’t approve generic versions of Premarin because there was no way to assure they had the same active ingredients and would be as effective. Premarin, the most frequently prescribed drug in the U.S., has annual worldwide sales of about $1 billion and helps prevent bone loss while relieving menopause symptoms. Duramed shares rose 44 cents to close at $4.375 on Nasdaq.

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