Compliance Management

Teva's Generic EpiPen Launch Will Be Delayed by FDA

Mar 01, 2016

Bloomberg

U.S. FDA cited “major deficiencies” in an application for a generic version of the EpiPen allergy-reaction injector from Teva Pharmaceutical Industries Ltd., according to a Bloomberg article.

Teva will respond to the FDA, but the company says the launch of its epinephrine injection will be “significantly delayed” until at least 2017.

The setback could be good news for Mylan’s specialty division, the story said. Read the Bloomberg article