Aurobindo Pharma gets US Regulator's Nod for Osteoporosis Drug
Wednesday, December 02, 2015
Aurobindo Pharma on Tuesday said it has received final approval from the US Food and Drug Administration (FDA) to manufacture and market a generic version of risedronate sodium tablets, used in the treatment of osteoporosis, in the American market.
The company has received final approval from the US Food and Drug Administration 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 are used in the treatment of osteoporosis.
The approved product has an estimated market size of $113 million for the twelve months ending October 2015, according to IMS data.
Shares in Aurobindo Pharma, on Tuesday, ended 1.8 per cent higher at Rs 825.25 apiece on the BSE, whose benchmark Sensex index finished up 0.09 per cent.
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