Aurobindo Pharma has received final nod from the US health regulator 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 (USFDA) 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.
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The product has an estimated market size of USD 125 million for 12 months ended April 2015, Aurobindo Pharma said quoting IMS data.
The capsules, a 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 USFDA.
Aurobindo Pharma stock closed marginally down at Rs 1,276.85 on the BSE.
