East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Aurobindo Pharma’s Perampanel Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Fycompa® Tablets, manufactured by Catalyst Pharmaceuticals, Inc.

Perampanel Tablets are indicated:

• For the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.
• As adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.