India-based global pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Amifampridine Tablets, 10 mg.
Amifampridine Tablets, 10 mg, are bioequivalent to the reference listed drug, Firdapse Tablets, 10 mg, from Catalyst Pharmaceuticals Inc, for the indication in the approved labeling. Firdapse Tablets are indicated for people aged 6 years and older living with Lambert-Eaton myasthenic syndrome (LEMS), to help maintain muscle strength and mobility.
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.
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