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Aurobindo Pharma Ltd has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market extended Phenytoin Sodium capsules USP, 100mg.
The approved ANDA (abbreviated new drug application) is bio-equivalent and therapeutically equivalent to the reference listed drug product (RLD) Dilantin of Parke-Davis division of Pfizer Inc.
Phenytoin Sodium capsules are 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 12 months ended April 30, 2015 according to IMS.
This is the 38th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-betalactam products.
They Hyderabad-based pharma major now has 199 ANDA approvals (172 final approvals including 9 from Aurolife Pharma LLC and 27, tentative approvals) from USFDA, a company release said.
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