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Aurobindo gets USFDA nod for epilepsy drug Perampanel

Aurobindo Pharma has received USFDA final approval for Perampanel tablets. The epilepsy drug comes in seven strengths from 2mg to 12mg. It is bioequivalent to the reference drug Fycompa by Catalyst. The approval covers Aurobindo’s APL Healthcare Unit-IV facility. The product treats partial-onset seizures in epilepsy patients. The US market for Perampanel is worth about 67 million dollars a year, according to IQVIA data. Aurobindo plans to launch the drug in the third quarter of fiscal 2027. The company now holds 599 final ANDA approvals from the USFDA. The approval adds to Aurobindo’s strong US generics portfolio. Epilepsy affects millions of patients in America. Generic launches help lower drug prices. Aurobindo said it will market the tablets through its US arm. Epilepsy affects millions of patients in America. Generic launches help lower drug prices. Aurobindo will market the tablets through its US arm. The approval strengthens its US generics portfolio.

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