The first true generic version of the EpiPen (epinephrine) auto-injector received FDA approval, the agency said on Thursday.
In a news release, the FDA said that Teva Pharmaceuticals USA was granted approval to market its generic versions of the EpiPen and EpiPen Jr "for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds."
"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," FDA Commissioner Scott Gottlieb, MD, said in a statement.
This will be the first generic version of the EpiPen, as manufacturer Mylan Pharmaceuticals -- which had been widely criticized for the high cost of the product -- previously launched an "authorized generic" version at a cost of $300 for a two-pack in December 2016. At the time, Reuters described the cost of the product as "a more than 50% discount." The company CEO also testified in front of Congress back in September 2016 about the high cost of the potentially life-saving product.
"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," Gottlieb said, citing the company's Drug Competition Action Plan announced last year, which is "especially committed to the development of generic copies of complex products."
The agency characterized the epinephrine autoinjector as a "combination product," because it consists of both a drug (epinephrine) and a device (the auto-injector), and noted that complex products can be "hard to copy" and don't face "timely generic competition."
"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 added.