Aurobindo Pharma, a mid-size pharmaceutical company, said Monday the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil Tablets, 20 mg (ANDA 203963). This product is expected to be launched by the fourth quarter of FY 2015-16.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) REVATIO™ (sildenafil citrate) Tablets 20 mg of Pfizer, Inc.

Sildenafil Tablets are used in the treatment of pulmonary arterial hypertension (high blood pressure in the lungs). The approved product has an estimated market size of USD 80 million for the twelve months ending September 2015 according to IMS.

"This is the 51st ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-antibiotic products", the company said.

Aurobindo now has a total of 219 ANDA approvals (190 final approvals including 10 from Aurolife Pharma LLC and 29 Tentative approvals) from USFDA.

Shares of the company gained Rs 12.85, or 1.54%, to trade at Rs 845. The total volume of shares traded was 11,742 at the BSE (9.21 a.m., Monday).