The shares of Teva Pharmaceutical Industries Ltd. surged in Tel Aviv on Sunday, following their rise on the New York Stock Exchange on Thursday, after the US Food and Drug Administration approved the Israel drugmaker’s generic version of the EpiPen auto-injector for the emergency treatment of allergic reactions.
Teva Pharmaceuticals’ US subsidiary got approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths, the FDA said in a statement.
Teva’s shares were trading 4.5 percent higher at 12:09 p.m. in Tel Aviv, following their rise in New York on Thursday and Friday.
The original EpiPen was marketed by Mylan NV, which has come under regulatory and political scrutiny in the past few years for the surging price of the life-saving device, at a time when regulators are seeking to lower the prices of drugs for patients.
“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 in a statement dated August 16.
“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.”
Allergy reactions can be life-threatening, and people at risk must always carry an emergency dose of epinephrine with them. The EpiPen is a medical device that is loaded with the medication, and can be directly injected into a person’s thigh to stop an allergic reaction.
The approval of Teva’s version comes after the Jerusalem-based drugmaker failed to get the regulatory approval needed for its generic EpiPen in 2016.