An old antibiotic is quietly becoming easier to get in the United States. Novartis obtained supplemental FDA approval for Lamprene, its brand of clofazimine, on July 27, and notified healthcare professionals on October 9, Endpoints News reported. Novartis told the publication it requested the approval to simplify how it distributes the drug in the US for the treatment of leprosy.
Lamprene’s US history is one of absence. Novartis stopped marketing it in the United States in 2024, and for years before that it was not available through ordinary pharmacies; the FDA’s own expanded access page describes clofazimine as unavailable in US pharmacies since marketing was discontinued, with leprosy patients supplied through the National Hansen’s Disease Program and other patients reaching it through managed access arrangements. Under the new approval the drug is available free through a specialty pharmacy, replacing that case by case process.
The financial stakes for Novartis are negligible. The clinical stakes are not: clofazimine is a component of multidrug therapy for leprosy and is used off label against drug resistant tuberculosis and nontuberculous mycobacterial infections, settings where the antibiotic arsenal is thin and every additional accessible agent matters.
Two cautions apply. The approval is a distribution and labeling change for an already approved drug, not a new efficacy finding. And the details in this story rest on a single trade report; Novartis has made no public release of its own, which is itself the point of the original reporting. The drug was too small to announce and too important to leave hard to reach.