Aurobindo Pharma receives USFDA Approval for Naproxen Sodium Tablets (OTC)

Aurobindo Pharma Limited 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 Q1 FY16-17.

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. The approved product has an estimated market size of US$ 96 million for the twelve months ending January 2016 according to IMS.

This is the 66 th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 245 ANDA approvals (210 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.

Shares of AUROBINDO PHARMA LTD. was last trading in BSE at Rs.720.9 as compared to the previous close of Rs. 726.15. The total number of shares traded during the day was 234460 in over 9004 trades.

The stock hit an intraday high of Rs. 726 and intraday low of 697.25. The net turnover during the day was Rs. 166659783.

Source : Equity Bulls

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