Teva Pharmaceuticals USA has received U.S. Food and Drug Administration approval to manufacture generic Fosamax.
Alendronate sodium tablets are indicated for the treatment of osteoporosis, a condition that causes thinning and weakening of the bones.
Approved dosages will be available in three once-daily dosages of 5 milligrams, 10 milligrams and 40 milligrams and the two once weekly dosages of 35 milligrams and 70 milligrams.
"The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."
Generic manufacturers must show that a generic drug has the same active ingredient, dosage form, strength, route of administration, quality and performance as the approved name brand drug.
Name-brand Fosamax had annual U.S. sales of approximately $1.9 billion for the period ending Sept 30 according to Teva.
[Source: MedlinePlus]
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