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Aurobindo Pharma Gets USFDA Nod for Generic Epilepsy Tablets
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News18•04-10-2026, 17:00
Aurobindo Pharma Gets USFDA Nod for Generic Epilepsy Tablets
- •Aurobindo Pharma received final USFDA approval for Perampanel tablets in various strengths.
- •The medication treats partial-onset seizures and primary generalized tonic-clonic seizures in epilepsy patients.
- •The approved drug is bioequivalent to Catalyst Pharmaceuticals' Fycompa Tablets.
- •Production will occur at APL Healthcare's Unit-IV, with a Q3 FY27 launch planned.
- •The estimated market size for the approved product is USD 67 million for the 12 months ending August 2026.
Key Questions Answered
Aurobindo Pharma received final USFDA approval to manufacture and market Perampanel tablets in various strengths.
The approved Perampanel product will be manufactured at Unit-IV of APL Healthcare, which is a wholly-owned subsidiary of Aurobindo Pharma.
The approved generic Perampanel tablets are bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals, Inc.'s reference listed drug, Fycompa Tablets.
