Lupin gets US FDA nod for Amifampridine Tablets

Lupin Limited has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Applications (ANDAs) for Amifampridine Tablets, 10 mg. These tablets are bioequivalent to Firdapse® Tablets, 10 mg, of Catalyst Pharmaceuticals, Inc. Lupin is among the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. This approval marks a significant milestone for Lupin in the U.S. market, expanding its portfolio of generic medications.