Pharma Company Receives U.S. FDA Approval for Amifampridine Tablets

Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg. The approval was announced on November 2, 2026. The company is among the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.

Amifampridine Tablets, 10 mg, have been approved as bioequivalent to the reference listed drug (RLD), Firdapse® Tablets, 10 mg, manufactured by Catalyst Pharmaceuticals, Inc. The product is approved for the indication specified in the U.S. FDA-approved labelling.

Amifampridine is used in the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune neuromuscular disorder in which communication between nerves and muscles is impaired. It can cause muscle weakness, particularly in the hips and thighs, and may also affect the arms and other muscle groups. The company's earlier announcement of tentative approval in March 2025 had specified the indication as treatment of LEMS in adults and paediatric patients aged six years and older. However, the latest approval announcement refers to the indication in the approved labelling.

The approval marks an addition to the company's generic pharmaceutical portfolio in the United States. The 180-day shared generic exclusivity eligibility applies to the product's generic market entry under the applicable U.S. regulatory provisions.

Source: https://news.docthub.com/pharma-company-receives-u-s-fda-approval-for-amifampridine-tablets-N2700