FDA Approves First EpiPen Generic

The US Food and Drug Administration (FDA) has approved the first generic version of both EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

The approval, granted to Teva Pharmaceuticals USA, indicates a generic version of the 0.3 mg- and 0.15 mg-strength injectors. The marketing is approved to include patients with life-threatening allergic reactions (anaphylaxis).

According to the FDA, anaphylaxis occurs in approximately 2% of all Americans, with those who have experienced a previous episode being at risk for another one. The epinephrine injector has been approved under several various product names over the years, and are intended for emergency patient use at the time of an event.

Life-threatening allergies linked to reactions requiring the injection include insect bites or stings, foods, medications, and latex. In some cases, untreated anaphylaxis can result in patient death.

Common side effects association with epinephrine injection include anxiety, tremor, dizziness, palpitations, nausea and vomiting, headache, and more. In rare instances, patients have reported cases of serious skin and soft tissue infection. The FDA advises that patients always seek immediate medical attention following epinephrine injection.

Scott Gottlieb, MD, commissioner of the FDA, said in a statement that the approval is part of the FDA’s commitment to progress patient access to less costly, safe, effective therapy options.

“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. “The path to developing generic drug-device combination products like this one is challenging.”

As a technical “combination therapy” because of its injection method-of-administration, the EpiPen generic was particularly more laborious to progress through FDA regulation. That said, Gottlieb reiterated their stance on fulfilling the promises of last year’s Drug Competition Action Plan.

“We’re especially committed to the development of generic copies of complex products,” Gottlieb said. “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.”