FDA approves first generic EpiPen

Today, the FDA granted approval to the first generic version of EpiPen and EpiPen Jr autoinjector for treating life-threatening allergic reactions, or anaphylaxis, to insect bites or stings, foods, medications, latex and other causes, in adults and children who weigh more than 33 pounds, according to a press release.

“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,” Scott Gottlieb, MD, FDA Commissioner, said in the release.

The generic epinephrine autoinjector, from Teva Pharmaceuticals USA, is designed to immediately and automatically inject epinephrine into an individual’s thigh and is approved in doses of either 0.3 mg or 0.15 mg, according to the FDA. The generic can benefit the one in 50 Americans who experience anaphylaxis and need to carry at least one emergency dose of epinephrine at all times by reducing swelling in the airway and allowing for more blood flow in the veins, according to the FDA.

Anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or respiratory difficulties are the most common adverse events related to epinephrine injection, according to the FDA. Although rare, serious skin and soft tissue infections may occur with epinephrine use, according to the FDA.

“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.

Disclosure: Gottlieb is an employee of the FDA.