FDA approves generic versions of Fosamax
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.
--
Copyright 2008 by United Press International.
All rights reserved.
--
|
Friends of Apples for Health
Affordable Health Insurance - Free, no obligation quotes on affordable health insurance
Texas Vacation Rentals - Family oriented lake house and cabin rentals on secluded guest ranch.
Pond Supplies-Water Treatments, Algae control, Pumps, Filtersand other Maintenance Product
