Global pharmaceutical leader Lupin Limited has secured tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg. This approval paves the way for Lupin’s entry into the market with a bioequivalent alternative to Firdapse® (10 mg) by Catalyst Pharmaceuticals, Inc.
What is Amifampridine Used For?
Amifampridine is an essential treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disorder that affects both adults and children (6 years and older). By offering a more accessible alternative, Lupin aims to enhance treatment options for patients suffering from this debilitating condition.
Manufacturing & Market Impact
The newly approved Amifampridine Tablets will be manufactured at Lupin’s Goa facility in India. This development strengthens Lupin’s position in the U.S. neurology and rare disease market.
With Firdapse® generating USD 306 million in global net sales for 2024, Lupin’s generic version is expected to boost affordability and accessibility for patients.
In the meantime, on March 7, the company introduced Rivaroxaban Tablets USP, 2.5 mg, in the U.S. market following final approval from the FDA for its Abbreviated New Drug Application (ANDA). This marks a significant milestone in providing a cost-effective alternative to Xarelto® (Janssen Pharmaceuticals, Inc.), a widely prescribed anticoagulant. Rivaroxaban is indicated for reducing major cardiovascular risks in patients with coronary artery disease (CAD) and lowering thrombotic vascular event risks in those with peripheral artery disease (PAD), including individuals who have recently undergone lower extremity revascularization.
