FDA Approves Teva's Generic EpiPen, Shares Up 6%

(RTTNews) - The U.S. Food and Drug Administration Thursday approved the first generic version of Mylan's EpiPen for the emergency treatment of allergic reactions. Teva Pharmaceuticals gained the US regulator's approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Shares of Teva gained 6 percent following the news and is currently trading at $23.91.

"Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," said FDA Commissioner Scott Gottlieb, M.D.

"This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

In 2016, FDA had rejected Teva's application for a generic EpiPen.

The EpiPen is intended to automatically inject a dose of epinephrine into a person's thigh to stop an allergic reaction. The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q.