The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
The U.S. Food and Drug Administration today took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date.
FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.
We have heard from members in our community that many are having trouble filling prescriptions for three of the four types of epinephrine auto-injectors: EpiPen® and EpiPen Jr® (distributed by Mylan) The authorized generic of EpiPen® and EpiPen Jr® (distributed by Mylan) Epinephrine injection, USP auto-injector, the authorized generic of Adrenaclick® (distributed by Impax) This is due to possible shortages at pharmacies. Kids With Food Allergies has confirmed there is no shortage of the drug...
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