Generic Fosamax approved
NEWS IN BRIEF — Posted Feb. 25, 2008
The first generic version of Fosamax, or alendronate sodium, used for treatment of osteoporosis was approved Feb. 6 by the Food and Drug Administration.
Fosamax is among the top 100 most frequently dispensed drugs in the United States, said the FDA, citing the magazine, Drug Topics.
Generic versions will be available in three strengths for once-daily doses -- 5 mg, 10 mg and 40 mg -- and two strengths for once-weekly doses -- 35 mg and 70 mg.
The tablets have been demonstrated to have the same active ingredient, dosage form, strength, route of administration, quality and performance characteristics as the brand-name version, but the labeling of the generic version may differ from that of Fosamax because some portions of the label are protected by patent and exclusivity, the agency said.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/02/25/hlbf0225.htm.