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Company Watch
Sun gets US FDA nod for Fosamax
Our News Bureau - Mumbai
 Sun
Pharmaceuticals has obtained final Food and Drug Administration (FDA) approval
for its Abbreviated New Drug Application (ANDA) generic, alendronate sodium
tablets. It has annual sales of approximately USD 560 million in the US and
will be in 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. 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 which is distributed by Merck.
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