Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC).
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Aleve Tablets, of Bayer Healthcare LLC (Bayer), the release said.
Naproxen Sodium Tablets are used for treatment and prevention of osteoporosis in postmenopausal women. The approved product has an estimated market size of US $96 million for 12 months ended January 2016, according to IMS.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Aleve Tablets, of Bayer Healthcare LLC (Bayer), the release said.
Naproxen Sodium Tablets are used for treatment and prevention of osteoporosis in postmenopausal women. The approved product has an estimated market size of US $96 million for 12 months ended January 2016, according to IMS.
