Aurobindo Pharma gets USFDA nod for osteoporosis drug


New Delhi: Aurobindo Pharma has received final nod from the US health regulator to manufacture and market its generic Naproxen Sodium tablets used for the treatment of osteoporosis in postmenopausal women.

“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Naproxen Sodium tablets USP, 220 mg,” Aurobindo Pharma said in a BSE filing.

The company expects to launch the product in the first quarter of the next fiscal, it added.

“The approved product has an estimated market size of $96 million for the twelve months ended January 2016 according to IMS,” it said.

The company’s drug is the generic version of Bayer Healthcare LLC’s Aleve tablets, it added. This is the 66th abbreviated new drug application (ANDA) (including 14 tentative approvals) to be approved out of the company’s Unit VII formulation facility in Hyderabad.

The company has a total of 245 ANDA approvals (210 final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from the USFDA, it added.