Lupin receives tentative approval from U.S. FDA for Amifampridine Tablets

Global pharma major Lupin Limited (Lupin) today 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.

Shares of Lupin Limited was last trading in BSE at Rs. 1969.05 as compared to the previous close of Rs. 1965.20. The total number of shares traded during the day was 10109 in over 2136 trades.

The stock hit an intraday high of Rs. 1985.45 and intraday low of 1950.85. The net turnover during the day was Rs. 19925413.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA TentativeApproval AmifampridineTablets