FDA to Review Re-Submitted Bristol-Myers Hepatitis C Drug
Thursday, March 12, 2015
Bristol-Myers Squibb Co said U.S. regulators have accepted the company's re-submitted marketing application for an experimental treatment for hepatitis C, following the drugmaker's decision last year to pull back its initial marketing request.
Bristol-Myers on Thursday said the U.S. Food and Drug Administration will review daclatasvir, its so-called NS5A inhibitor, for use in combination with Gilead Sciences Inc's potent and widely used Sovaldi treatment. It said the FDA is expected to make its decision within six months.