Aurobindo Pharma Gets USFDA Nod for Epilepsy Drug Perampanel, Targets USD 67 Mn US Market
New Delhi: Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Perampanel Tablets in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fycompa Tablets, of Catalyst Pharmaceuticals, Inc.
The product will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, and is scheduled to be launched in the US market in the third quarter of FY2026-27.
According to IQVIA MAT data for the 12 months ended August 2026, the approved product has an estimated US market size of USD 67 million.
With this approval, Aurobindo Pharma said it now has a total of 599 ANDA approvals from the USFDA, comprising 574 final approvals and 25 tentative approvals.
Perampanel Tablets are indicated for the treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged four years and older. The medicine is also indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures and commercializes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients across more than 150 countries.
The company has more than 30 manufacturing and packaging facilities approved by regulatory agencies including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA and others.
Its product portfolio spans seven major therapeutic and product areas, including CNS, anti-retroviral, cardiovascular, antibiotics, gastroenterological, anti-diabetic and anti-allergic segments, supported by its research and development capabilities.
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