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
Aurobindo Pharma has received the final approval from the US Food and Drug Administration (US FDA) 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 $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 nine from Aurolife Pharma LLC and 27 tentative approvals) from US FDA.
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