First Generic EpiPen Autoinjector Gains FDA Approval
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Posted on Aug 16, 2018, 9 p.m.
Mylan’s EpiPen and EpiPen Jr epinephrine autoinjectors are the first generic versions to gain FDA approval, in a move that can help increase access to emergency treatment for allergic reactions; and is part of broader federal mandates to help lower costs of medications that not protected by patents or exclusions.
Approval was granted for Teva Pharmaceuticals generic epinephrine autoinjectors in 0.3mg and 0.15mg strengths to be used in adults and children weighing more than 33lbs. Approval means severe allergy patients requiring constant access to epinephrine may have lower costs options, and another approved product can help to protect against drug shortages.
EpiPens can be found to be in short supply, with spot shortages continuing after FDA investigations found problems with current manufacturers and added another EpiPen and injectors manufacturer to its drug shortages list. FDA has said it is working on new guidance for generic sponsors of complex products and is prioritizing review of such applications.
Developing generic drug device combination products can be challenging, agency and researchers are committed to providing scientific and regulatory clarity for sponsors seeking development, and prioritize approval of medicines with little to no generic competition as part of efforts to remove barriers to generic development and market entry of important medications.
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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617173.htm
