The generic version, which comes from Israeli company Teva Pharmaceuticals, is also an auto-injector that delivers a dose of ephinephrine to treat an allergic reaction, called anaphylaxis.
“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,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “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.”
There is currently a major shortage of the name-brand EpiPens, which come from Mylan, due to a supply and manufacturer issues. The FDA added EpiPens to their list of drug shortages on May 9, and Mylan confirmed that the shortages are still ongoing on Aug. 8.
Mylan’s EpiPens have long dominated the market, but have been the target of criticism over the last few years. Since the company took over manufacturing EpiPens in 2007, the price has increased by more than 400 percent from just $57 to over $500 in 2016.
And in March 2017, Mylan had to recall tens of thousands of EpiPens after two families reported that the injectors had failed to work during an emergency. That September, the FDA issued a warning to the manufacturer because it did not properly investigate issues at a plant in Missouri or resolve the complaints about the EpiPens failing in emergencies.
The FDA said that they’re hoping to approve more generic autoinjectors to “remove barriers to generic development and market entry of critically important medicines.”
“We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications,” Gottlieb said.