FDA approves Aurobindo’s generic osteoporosis drug
NEW YORK The Food and Drug Administration has granted final approval to Aurobindo Pharma to market a generic version of Merck’s Fosamax tablets.
The tablets, whose active ingredient is alendronate sodium, will be available in strengths of 10, 35 and 70 mg for the treatment of osteoporosis. This is India-based Aurobindo’s 73rd approval from the FDA.
Fosamax and Fosamax Plus D (alendronate sodium/cholecalciferol) had worldwide sales of $411 million, according to Merck financial data.