Aurobindo gains 2%; gets final USFDA approval for OTC drug

Moneycontrol BureauShares of Aurobindo Pharma gained more than 2 percent intraday Monday as it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC).This product is expected to be launched in Q1FY16-17."The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aleve Tablets, of Bayer Healthcare LLC (Bayer). Naproxen Sodium Tablets is used in the treatment and prevention of osteoporosis in postmenopausal women," as per BSE release. "The approved product has an estimated market size of USD 96 million for the twelve months ending January 2016 according to IMS.""Aurobindo now has a total of 245 ANDA approvals (210 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA," it added. At 09:29 hrs Aurobindo Pharma was quoting at Rs 734.40, up Rs 13.50, or 1.87 percent on the BSE.Posted By Rakesh Patil