Stories
Aurobindo Pharma Secures USFDA Approval for Perampanel Tablets
- •Aurobindo Pharma received final USFDA approval for Perampanel tablets in multiple strengths (2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg).
- •The approved tablets are bioequivalent and therapeutically equivalent to Fycompa tablets by Catalyst Pharmaceuticals, Inc.
- •Perampanel tablets are indicated for partial-onset seizures and primary generalized tonic-clonic seizures in epilepsy patients.
- •The product will be manufactured at APL Healthcare's Unit-IV and is expected to launch in Q3 FY27, targeting an estimated US market size of $67 million.
- •Aurobindo Pharma now holds 599 ANDA approvals from the USFDA, including 574 final and 25 tentative approvals.
Key Questions Answered
Aurobindo Pharma received final approval from the US Food and Drug Administration to manufacture and market Perampanel tablets in strengths ranging from 2 mg to 12 mg. The approved tablets are bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals' reference listed drug Fycompa tablets. Manufactured at Unit-IV of APL Healthcare, the product is scheduled to launch in Q3 FY27.
Perampanel tablets are indicated to treat partial-onset seizures in epilepsy patients aged 4 years and older, and as an adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 12 and older. According to IQVIA MAT, the approved product holds an estimated US market size of $67 million for the 12 months ended August 2026. This approval brings Aurobindo's total USFDA ANDA approvals to 599.
Adquey is Aurobindo Pharma's first novel drug in the US market, originally discovered by Otsuka Pharmaceutical and licensed to Acrotech. It is a non-steroidal topical PDE4 inhibitor used for treating mild-to-moderate atopic dermatitis in adults and children aged two and older, with patent protection until 2036. The launch marks Acrotech's entry into the US dermatology market, supported by a newly established dedicated business unit.
