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FDA to review re-submitted Bristol-Myers hepatitis C drug
March 12, 2015 / 7:22 PM / 3 years ago

FDA to review re-submitted Bristol-Myers hepatitis C drug

March 12 (Reuters) - 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.

Reporting by Ransdell Pierson; Editing by Chris Reese

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