Lupin bags tentative USFDA nod for rare autoimmune disorder drug Amifampridine

Mumbai: Global pharma major Lupin Limited has announced that it 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.

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Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.

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