September 15, 2008
Sun Pharma Wins FDA Approval for Generic Osteoporosis Drug
Sun Pharmaceutical Industries, a specialty pharmaceutical company, has announced that the FDA has granted final approval for the company's abbreviated new drug application for generic Fosamax, alendronate sodium tablets.
These generic versions of alendronate sodium tablets 5mg (base), 10mg (base), 35mg (base) and 70mg (base) are bio-equivalent to Fosamax tablets distributed by Merck & Co. These products will reach market shortly.
Alendronate sodium tablets are indicated for the treatment and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget's disease of the bone in men and women.