Aurobindo Pharma 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 Abbreviated New Drug Application (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 $96 million for the twelve months ending January 2016 according to IMS. 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. The company now has a total of 245 ANDA approvals (210 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.
