US FDA has granted final approval for Sun Pharmaceutical Industries Ltd's Abbreviated New Drug Application (ANDA) for generic Fosamax, alendronate sodium tablets.
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.
These generic versions of alendronate sodium tablets 5 mg (base), 10 mg (base), 35 mg (base) and 70 mg (base) are bio-equivalent to Fosamax tablets distributed by Merck & Co. These strengths of Fosamax tablets have annual sales of approximately USD 560 million in the US. These products will reach market shortly.