Aurobindo Pharma Gets US Regulator's Nod for Anti-Epileptic Drug

New Delhi: Aurobindo Pharma has received final approval from the US Food and Drug Administration (FDA) to make and market generic anti-epileptic Phenytoin Sodium capsules in America.

"The company has received the final approval from the US Food & Drug Administration (FDA) to manufacture and market extended Phenytoin Sodium capsules USP, 100mg," Aurobindo Pharma said in a statement.

The approved abbreviated new drug application (ANDA) is for the generic version of Pfizer Inc Parke-Davis Division's Dilantin capsules.

The product has an estimated market size of $125 million for 12 months ended April 2015, Aurobindo Pharma said quoting IMS data.

The capsules, an anti-epileptic product, is indicated for the control of seizures and prevention and treatment of seizures occurring during or following neurosurgery, it added.

The company currently has a total of 199 ANDA approvals (172 final approvals including 9 from Aurolife Pharma LLC and 27 tentative approvals) from the US health regulator.

Aurobindo Pharma stock, on Monday, ended marginally lower at Rs 1,276.85 apiece on the BSE.