Lupin gets tentative FDA nod for amifampridine tablets

Lupin Limited (BSE: LUPIN) announced today it has secured tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg. The product, a generic version of Catalyst Pharmaceuticals' Firdapse, is indicated for treating Lambert-Eaton myasthenic syndrome in adult and pediatric patients ages six and older. Lupin will manufacture the drug at its Goa facility in India. According to the company, Amifampridine Tablets, 10 mg (RLD Firdapse), had an estimated global net sale of USD 306 million for the fiscal year ended December 31, 2024.