The U.S. Food and Drug Administration (FDA) has tentatively approved Lupin’s generic version of Firdapse (amifampridine) for people with Lambert-Eaton myasthenic syndrome (LEMS), ages 6 and older, according to a company press release. This means the treatment satisfies all the requirements to be marketed in the U.S.

An agreement between Catalyst Pharmaceuticals and Teva Pharmaceuticals has ended a U.S. patent litigation case that began when Teva applied to produce and market a generic version of Firdapse (amifampridine) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). Under the terms of the settlement, announced…

Teva Pharmaceuticals is seeking authorization from federal regulators in the U.S. to produce and sell a generic version of Firdapse (amifampridine), an approved treatment for Lambert-Eaton myasthenic syndrome (LEMS). Firdapse, marketed by Catalyst Pharmaceuticals, was approved by the U.S. Food and Drug Administration in 2018 as the…

A branch of the European Medicines Agency (EMA) has recommended that Amifampridine SERB, a generic version of Firdapse, be approved to treat adults with Lambert‑Eaton myasthenic syndrome (LEMS) in the European Union. The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), will now…

The Orphan Drug Act (ODA) has spurred the development of treatments for rare diseases, such as Lambert-Eaton myasthenic syndrome (LEMS), according to a recent report. Yet, patient advocates say that a better balance between development incentives and competition might benefit the rare disease community. The report, “…