FDA Approves First Generic EpiPen

The FDA has approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the treatment of allergic reactions, including anaphylaxis, in adults and children over 33 pounds.

The generic epinephrine auto-injector will be available in 2 doses: 0.3 mg and 0.15 mg.

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The most common side effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache and/or respiratory difficulties.

““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,” said FDA Commissioner Scott Gottlieb, MD.

—Michael Potts

Reference:

FDA. FDA approves first generic version of EpiPen [press release]. August 16, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM617173.htm?utm_campaign=08162018_PR_FDA%20approves%20first%20generic%20version%20of%20EpiPen&utm_medium=email&utm_source=Eloqua.