Lupin Wins FDA Approval for Amifampridine Tablets
The FDA approved Lupin’s 10 mg amifampridine tablets, bioequivalent to Firdapse. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.
Lupin Limited received U.S. FDA approval for its 10 mg amifampridine tablets, bioequivalent to Firdapse. It is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.Material DetailsContext by AI AnalystThis is a concrete regulatory and product milestone, but th…