Teva Snags FDA Approval for Generic EpiPen
Shares of Teva Pharmaceuticals jumped more than 7 percent in afternoon trading Thursday and continue to rise in premarket trading this morning after the U.S. Food and Drug Administration (FDA) approved the company’s generic version of the EpiPen Auto-Injector.
This is the first generic version of the widely used EpiPen made by Mylan. The rising consumer cost of the branded EpiPen reached a national furor a few years ago when the price hit more than $600 for a two-pack of the life-saving epinephrine injector. Teva’s generic version of the EpiPen and EpiPen Jr. was approved for use in adults and pediatric patients who weigh more than 33 pounds.
The approval for Teva has been a long time coming. In 2016 the FDA rejected Teva’s initial attempts at garnering approval for its generic version. Now though, the company can prepare to take on Mylan, which is the dominant player in the space. Despite the pricing controversies from a few years ago, Mylan’s Epi-Pens are the go-to safety net for patients who could face anaphylaxis from a bad reaction to an allergen. Anaphylaxis occurs in approximately one in 50 Americans. It could lead to death.
FDA Commissioner Scott Gottlieb said the approval of the “first generic version of the most-widely prescribed epinephrine auto-injector” is part of the FDA’s drive to provide safe and cost-effective treatments for patients.
“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,” Gottlieb said in a statement.
There are other epinephrine auto-injectors on the market, such as Adrenaclick and Auvi-Q, but they are not considered generic versions of the EpiPen. Mylan did introduce its own authorized generic version of its EpiPen, which costs $300 for a two-pack.
In a brief statement, Brendan O’Grady, head of Teva’s North America Commercial division, said the FDA approval is an important step in bringing additional epinephrine auto-injector options to patients. The company noted that it is “applying its full resources” to the launch of the generic auto-injector and is “eager to begin supplying the market.”
The EpiPen Auto-Injector delivers a precise dose of life-saving epinephrine for severe allergic reactions.
Earlier this year the FDA noted there was a shortage of EpiPen and other epinephrine injectors in the United States due to manufacturing issues. A Pfizer division manufactures Mylan’s EpiPen. In the fall of 2017, the FDA berated Meridian Medical Technologies, Inc., the division that makes the auto-injector, over its manufacturing problems. Some of the auto-injectors failed to operate, which led to the death of a few people from anaphylaxis.
Last year the FDA introduced new guidance to “remove barriers to generic development and market entry of critically important medicines,” Gottlieb noted in his statement.