Lupin receives USFDA tentative approval for Amifampridine Tablets

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Amifampridine Tablets, 10 mg. This product would be manufactured at Lupin's Goa facility in India.

Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse' Tablets, 10 mg of Catalyst Pharmaceuticals, Inc., and are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.

Amifampridine Tablets, 10 mg (RLD Firdapse') had an estimated global net sale of USD 306 million for the fiscal year ended December 31, 2024.