WASHINGTON—The Food and Drug Administration approved Teva Pharmaceutical Industries Ltd.’s generic version of Mylan’s EpiPen injector device for life-threatening allergic reactions, the most widely sold such device in the U.S.
The product, whose brand-name version is manufactured by Mylan NV, touched off a furor two years ago over its price increases of 548% over about a decade.
The approval of a generic version of this product marks something of a milestone for FDA Commissioner Scott Gottlieb. Dr. Gottlieb has made approval of generics a high priority for the agency, including products commonly referred to as complex generics.
These are drugs that have long been available under pricey brand names but were difficult to approve as generics because of complex means of administration, like nose sprays or injections. The EpiPen is one of the first such approvals.
“We’re especially committed to the development of generic copies of complex products,” Dr. Gottlieb said Thursday. “These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval.”
EpiPens are crucial emergency products for people, including many children, who suffer allergic reactions. Mylan was under severe criticism from the public and Congress in 2016 after raising its list price for a pack of two auto-injectors to $609.
The drug is automatically injected into a person’s thigh to stop an allergic reaction, the symptoms of which typically include dizziness, vomiting and difficulty breathing. The medicine has a rapid onset and short duration, and works by reducing airway swelling and increasing blood flow in the veins.
—Jonathan D. Rockoff contributed to this article.