FDA approves first generic version of epinephrine auto-injector

The US Food and Drug Administration (FDA) has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions.

“[The] approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US 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,” said FDA commissioner Dr Scott Gottlieb. “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.”

Epinephrine auto-injector products are known as ‘combination products’ because they consist of a drug (epinephrine) and a device (the auto-injector). Development of a generic product that combines a drug with a device can be more complicated than for other simple drug products.

To assist, the FDA has worked with individual companies to support their development of complex products and has created publicly available guidances to outline each step of the process that are recommended for submission of complete, approvable applications. For epinephrine auto-injectors, for example, the FDA has published three draft guidances since 2009.

“The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritise the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines,” Gottlieb added. “Many of these steps were outlined in our Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products. 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. We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritising review of many complex generic drug applications.”

Life-threatening allergies can include reactions to insect bites or stings, foods, medications, latex or other causes and in cases of anaphylaxis, which affects the whole body, can lead to death. If a person has had an anaphylaxis episode there is always the risk of suffering another one and as such it is important for these people to carry an emergency dose of epinephrine at all times.

This epinephrine injection (auto-injector) is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

The FDA approval was granted to Teva Pharmaceuticals USA, which can now market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.