Aurobindo Pharma Rallies As Company Gets US FDA Approval

Business

oi-Sunil

By Sunil Fernandes

Published: Monday, November 23, 2015, 12:10 [IST]

Shares in Aurobindo Pharma was trading 2 per cent higher after the company said it has received USFDA's approval for Sildenafil Tablets, 20mg.

The product is expected to be launched by Q4 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 US$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. Aurobindo now has a total of 219 ANDA approvals (190 Final approvals including 10 from Aurolife Pharma LLC and 29 Tentative approvals) from USFDA.

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