FDA Approves First Generic EpiPen
Life-saving drugs are important to individuals who suffer from chronic conditions such as severe allergies. A severe allergic reaction can cause anaphylaxis within seconds of being exposed to an allergen. Anaphylaxis is a potentially life-threatening reaction that can cause blood pressure to drop, airways to tighten, dizziness, fainting, and a swollen tongue or throat.
Common allergy triggers include exposure to latex, certain foods, insect venom, or some medications. Because some of these potential triggers are so common, many individuals who suffer from extreme allergic reactions carry an epinephrine auto-injector, which counteracts an allergic reaction in an emergency.
The drug manufacturer Mylan has produced the most commonly prescribed epinephrine auto-injectors known as EpiPen and EpiPen Jr. Mylan has reported supply issues for their pens, limiting the availability of these life-saving products at times. This includes their own authorized generic version of the EpiPen.
These supply interruptions can be problematic, but as the patents for the EpiPen and similar products expire, there is more opportunity for the independent production of a generic version of this drug, increasing the availability of the product.
But there have been some delays getting a generic version approved.
The EpiPen is a combination product, consisting of a drug and a device, which has made the approval of a generic option difficult, even after patents expired. After a long process, the FDA has approved a generic epinephrine auto-injector in the US that should increase the availability of these products.
Teva Pharmaceuticals has announced that they will be marketing epinephrine auto injectors in 0.15 and 0.3mg strengths. In a statement, Teva has said that they are “applying [their] full resources” to the generic EpiPen and are “eager to begin supplying the market”.
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