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FDA OKs First Generic Fosamax

Generic Versions of the Osteoporosis Drug Fosamax Shipped to Stores

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

Feb. 6, 2008 -- The FDA today approved the first generic versions of the osteoporosis drug Fosamax (alendronate).

Teva Pharmaceuticals will make generic Fosamax in 5-milligram, 10-milligram, and 40-milligram daily doses, and in 35-milligram and 70-milligram weekly doses. Barr Pharmaceuticals Inc. will make generic Fosamax in 70-milligram tablets, which are taken once a week. Teva and Barr have already begun shipping their generic versions of Fosamax to stores.

The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," says Gary Buehler, RPh, director of the FDA's Office of Generic Drugs, in an FDA news release. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."

The FDA notes that Fosamax, which is made by the drug company Merck, is among the top 100 most frequently dispensed drugs in the U.S. Fosamax had annual sales of about $1.7 billion in the U.S. for the year ending in November 2007, states a Barr news release.

SOURCES: News release, FDA. News release, Barr Pharmaceuticals Inc. Email from Carol Cox, senior vice president, Global Investor Relations and Corporate Communications, Barr Pharmaceuticals Inc. News release, Teva Pharmaceuticals Ltd.

© 2008 WebMD Inc. All rights reserved.



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