FDA approves generic versions of Fosamax

Feb. 7, 2008 at 9:17 AM
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WASHINGTON, Feb. 7 (UPI) -- The U.S. Food and Drug Administration has approved the first generic versions of the osteoporosis drug Fosamax (alendronate sodium tablets).

Teva Pharmaceuticals USA of North Wales, Pa., was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths -- 5 milligrams, 10 milligrams, and 40 milligrams -- and two once-weekly dosing strengths of 35 milligrams and 70 milligrams.

Barr Laboratories Inc. of Montvale, N.J., was approved to manufacture a 70 milligram once-weekly dose of the drug.

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

Fosamax is among the top 100 most frequently dispensed drugs in the United States, the trade magazine Drug Topics said.

The FDA said labeling of the generic drug might differ from that of Fosamax because some portions of the labeling are protected by patents and exclusivity.

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