FDA Office of Generic Drugs approves first generic for EpiPen (epinephrine injection USP), 0.3 mg and EpiPen Jr (epinephrine injection USP), 0.15 mg

FDA Office of Generic Drugs approves first generic

for EpiPen (epinephrine injection USP), 0.3 mg

and EpiPen Jr (epinephrine injection USP), 0.15 mg

The U.S. Food and Drug Administration (FDA) today approved the first generic version of EpiPen/EpiPen Jr. This approval is for a complex generic drug-device combination product for which no generic previously existed.

Access to epinephrine auto-injectors is imperative for people living with severe allergies who rely on this potentially life-saving drug when they are experiencing a severe allergic reaction, including anaphylaxis. Today’s approval provides more access to this medication for these patients.

Epinephrine Injection (auto-injector) is FDA-approved for the emergency treatment of severe allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Anaphylaxis occurs in about 1 in 50 Americans. Currently EpiPen/EpiPen Jr. is the most commonly prescribed epinephrine drug product in the United States.

Epinephrine Injection (auto-injector) is intended for immediate administration in patients who are at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Epinephrine Injection (auto-injector) is intended for immediate administration as emergency supportive therapy only and not a substitute for immediate medical care.

Generic drugs are approved once they have met rigorous evaluation for equivalence with the brand name product. The generic must also meet the same high quality requirements for manufacturing and packaging as the brand name drug.  FDA prioritized the review of this abbreviated new drug application (ANDA) as a potential first generic.

More information on EpiPen and EpiPen Jr may be found within the drug label. Search Drugs@FDA for the drug labels of FDA-approved drug products. Visit the First Generic Drug Approvals page to view a full list of first generic drug approvals.  

FDA News Release – FDA approves first generic version of EpiPen