Home » Drugmakers Unlikely to Pursue Generic Xifaxan Anytime Soon
Drugmakers Unlikely to Pursue Generic Xifaxan Anytime Soon
The FDA’s rigorous new bioequivalence roadmap for Salix Pharmaceuticals’ diarrhea drug Xifaxan and the antibiotic’s long-term patents likely mean scant drugmaker interest in pursuing a generic anytime soon, according to a Wall Street analyst. New draft FDA guidance on proving bioequivalence to Xifaxan (rifaximin) requires an extensive study and only covers one of the drug’s two U.S.-approved indications — traveler’s diarrhea — at a soon-to-be-obsolete dose of 200 mg. That makes it unlikely any generic-drug maker will conduct the study, Jefferies analyst Corey Davis said in a Nov. 30 note.
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