FDA Accepts Theravance & Mylan’s NDA for Review

The NDA is for an investigational long-acting muscarinic antagonist (LAMA)

Theravance Biopharma and Mylan announced that the U.S. Food and Drug Administration (FDA) has accepted the companies’ recently submitted New Drug Application (NDA) for revefenacin (TD-4208) for review.     If approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 13, 2018.   “The acceptan...

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