India, Nov. 2 -- Lupin Ltd. (LUPIN.NS) said Monday the U.S. Food and Drug Administration approved its abbreviated new drug applications (ANDA) for amifampridine tablets, 10 mg.
The tablets are bioequivalent to Catalyst Pharmaceuticals' Firdapse tablets, 10 mg, for the indication specified in the approved labeling.
In its earlier tentative-approval announcement on March 17, 2025, Lupin identified the indication as Lambert-Eaton myasthenic syndrome (LEMS) in adults and children aged six and older. LEMS is a rare disorder that disrupts communication between nerves and muscles, causing muscle weakness.
Lupin said it is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.
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