From US FDA
Aurobindo Pharma 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 US$125 Million for the twelve months ending April 2015 according to IMS.
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