FDA gives Lupin tentative nod for generic Firdapse
Amifampridine tablets are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.
Lupin has received tentative approval from the Food and Drug Administration for amifampridine tablets, 10 mg.
Amifampridine tablets are the generic of Catalyst Pharmaceuticals’ Firdapse tablets. They are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.
[Read more: Lupin launches generic Minzoya]
Amifampridine tablets, 10 mg (RLD Firdapse) had a market value of $306 million for the fiscal year ended Dec. 31, 2024, Lupin noted.
This product will be manufactured at Lupin’s Goa, India, facility.
[Read more: Lupin launches generic Xarelto]
