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

March 12, 2015 7:29 PM

3 0

(Reuters) - U.S. regulators have accepted Bristol-Myers Squibb Co's re-submitted marketing application for an experimental hepatitis C treatment after the drugmaker was forced last year to withdraw its initial 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.

Also read: National Cancer Institute Says Researchers Didn’t Quickly Tell FDA After Two Deaths in a Lymphoma Study

Read more

To category page