Aurobindo Pharma receives USFDA approval for Naproxen Sodium Tablets (OTC)
Aurobindo Pharma Limited is pleased to announce that the company 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.
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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.
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This is the 66th 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.