FDA Approves First Generic Version of EpiPen

FDA Approves First Generic Version of EpiPen

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The FDA recently approved generic versions of EpiPen and Epipen Jr Auto-Injectors which are indicated for the emergency treatment of allergic reactions including anaphylaxis to stinging insects, food and drugs. Individuals with severe allergies are typically advised to carry an EpiPen at all times.  Annually, there are an estimated 3.6 million prescriptions for EpiPens written in the United States.

Epinephrine for self-injection is approved as a drug-device combination for both the drug and the injector mechanism and the complicated regulatory pathway has limited the entry of generic manufactures into the market.  However, recent drug shortages and/or exorbitant pricing may have made generic epinephrine auto-injectors a more attractive product.  

Injectable epinephrine for self-injection is currently supplied by Mylan (EpiPen and EpiPen Jr, ~$600 for two), Impax Generics (an authorized generic, which is EpiPen, but re-packaged and marketed as a generic, AdrenaClick, ~$300 for two) and Kaleo (Auvi-Q, ~$4500 for two). Auvi-Q is available and not in shortage, but only by a direct delivery plan from the manufacturer.  Due to the high cost, many insurers, including Medicare/Medicaid do not cover this formulation.   Both the Mylan and Impax formulations, manufactured by Meridian Medical Technologies are currently in shortage due to manufacturing delays which are likely related to a recent FDA warning letter, which cited Meridian for violating good manufacturing practices, not following up on consumer complaints and not performing adequate quality control.  In addition to quality issues, Mylan is under harsh scrutiny over EpiPen pricing, including Congressional hearings culminating in a $465 million dollar settlement with the US Department of Justice for overcharging the government for EpiPens.  A class action racketeering lawsuit is also ongoing.  

Teva Pharmaceuticals USA will market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths and given the cost, quality and availability concerns of the currently available formulations, it will be a welcome addition.  

Additional information about epinephrine can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.

Read more at: 

FDA warning letter

FDA Drug Shortages

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