India's Aurobindo Pharma gains on USFDA approval for generic osteoporosis drug

Monday, Aug 31, 2015

Shares of Aurobindo Pharma gained 3.3 per cent in trade on Monday, after the company got US FDA nod for generic osteoporosis drug.

The stock hit day's high of Rs 779.70 on the BSE.

The pharmaceutical company said that it has received approval from the US FDA to manufacture and market its generic version of Eli Lilly's Evista tablets used to treat and prevent osteoporosis in postmenopausal women.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Evista Tablets, 60mg of Eli Lilly, the company said in a filing to BSE.

Raloxifene Hydrochloride Tablets are indicated for treatment and prevention of osteoporosis in postmenopausal women. The product has an estimated market size of $404 million for the twelve months ending June 2015 according to IMS, the statement added.

This is the 45th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 210 ANDA approvals (182 Final approvals including 9 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.

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