New Delhi: Aurobindo Pharma today said it has received final approval from USFDA to manufacture and market generic version of Risedronate Sodium tablets, used in the treatment of Osteoporosis, in the American market.
The company has received final approval from US Food & Drug Administration (USFDA) to manufacture and market Risedronate Sodium tablets, Aurobindo Pharma said in a statement.
The approval is an extension of tentative nod received by the company on October 10, 2012, it added.
“This product is ready for launch,” the company added.
Aurobindo’s product is therapeutically equivalent to Warner Chilcott Co’s Actonel tablets, which is used in the treatment of Osteoporosis.
The approved product has an estimated market size of USD 113 million for the twelve months ending October 2015, according to IMS data.