Lupin wins USFDA approval for amifampridine tablets
In short
Lupin got USFDA approval for Amifampridine Tablets, 10 mg. The company is also eligible for 180 days of shared generic exclusivity.
The drug is said to match Catalyst Pharmaceuticals’ Firdapse Tablets, 10 mg. The reporting does not say when Lupin will launch it or how much money it could make.
What the reporting says
Lupin received USFDA approval for Amifampridine Tablets, 10 mg, and was said to be eligible for 180 days of shared generic exclusivity as one of the first applicants to file. The publisher-supplied summary says the product is bioequivalent to Catalyst Pharmaceuticals’ Firdapse Tablets, 10 mg. The immediate significance is a potential generic launch opportunity, while the reporting does not state launch timing or expected sales.
Why it matters
Lupin secured USFDA approval for its Amifampridine Tablets, 10 mg, and the summary says it qualifies for 180 days of shared generic exclusivity as one of the first filers. That can support a period of reduced competition if a launch follows. The reporting identifies the reference product as Catalyst Pharmaceuticals’ Firdapse Tablets, 10 mg, but does not provide launch timing or commercial estimates.