Aurobindo Pharma Gets USFDA Approval for Perampanel Tablets

Aurobindo Pharma Limited announced it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets in various dosages (2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg). These tablets are bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals' Fycompa® Tablets. The product will be manufactured at Aurobindo's wholly-owned subsidiary, APL Healthcare's Unit-IV, and is slated for launch in Q3FY27. The approved product targets an estimated market size of US$ 67 million. This approval adds to Aurobindo's portfolio, bringing their total USFDA ANDA approvals to 599 (574 final, 25 tentative). Perampanel Tablets are indicated for epilepsy treatment.