Aurobindo Pharma, a mid-size pharmaceutical company, announced that the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market extended
Phenytoin Sodium Capsules USP, 100mg (ANDA 204309).

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Dilantin® of Parke-Davis Division of Pfizer Inc.

Phenytoin Sodium Extended Capsules is an anti-epileptic product and indicated for the control of seizures and prevention and treatment of seizures occurring during or following neurosurgery. The product has an estimated market size of USD 125 million for the twelve months ending April 2015 according to IMS.

This is the 38th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-betalactam products. Aurobindo now has a total of 199 ANDA approvals (172 Final approvals including 9 from Aurolife Pharma LLC and 27 Tentative approvals) from USFDA.

Shares of the company declined Rs 0.65, or 0.05%, to settle at Rs 1,276.85. The total volume of shares traded was 94,079 at the BSE (Monday).