The US Food and Drug Administration (FDA) has approved the first generic version of the EpiPen to treat allergic reactions in emergency cases, including life-threatening (anaphylaxis) conditions.
The authorisation, granted to Teva Pharmaceuticals, also covers EpiPen Jr auto-injector. The approval is for the use of 0.3mg and 0.15mg products in adults and paediatrics weighing more than 33 pounds.
Mylan designed EpiPen for automatic injection of an epinephrine dose into a person’s thigh in order to halt an allergic reaction caused due to insect bites or stings, medicines or food, among others.
The epinephrine auto-injectors must be administered immediately in case of an allergic emergency. Epinephrine decreases swelling in the airway and increases blood flow in the veins.
The new EpiPen generic version will also work in a similar manner. Teva said that it will commercially launch the generic products over the coming months.
FDA commissioner Scott Gottlieb said: “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.
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“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.”
Anaphylaxis is a medical emergency that affects the whole body and can potentially result in death. People who experienced an anaphylaxis episode are at the risk of another one, and have to carry an emergency dose of epinephrine at all times.
Besides EpiPen, the FDA has approved multiple epinephrine auto-injectors such as Adrenaclick and Auvi-Q for treating anaphylaxis. A genetic version of Adrenaclick is also available in the market.