USFDA gives nod to Aurobindo Pharma's epileptic drug

The US Food & Drug Administration (USFDA) has granted its final approval to Aurobindo Pharma Limited for manufacturing and marketing extended phenytoin sodium capsules (100 mg). 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. According to IMS, the product has an estimated market size of $ 125 million for the twelve months ending April 2015.