Aurobindo Pharma gets final nod for osteoporosis drug

Aurobindo Pharma Limited is announced today that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Tablets, 150 mg. This product is expected to be launched in the first quarter of the year 2016-17. Ibandronate Sodium tablets are used in the treatment and prevention of osteoporosis in postmenopausal women.

The approved product has an estimated market size of $55 million for the twelve months ending January 2016, the company said quoting the IMS Health data. The approved ANDA (abbreviated new drug application) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva Tablets of Hoffman-La Roche Inc.