The auto-injector is for adult and pediatric patients who weigh more than 33 pounds. The company can now market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
Some life-threatening allergies can include reaction to insect bites or stings, foods, medications, latex or other causes. Anaphylaxis is a medical emergency that can affect the whole body and in some cases, can lead to death. Anaphylaxis is considered to occur in about one in 50 Americans.
People with anaphylaxis episode are always at a risk of another one. Due to this risk, they must carry an emergency dose of epinephrine at all times and many of them must keep more than one dose at hand.
FDA commissioner Scott Gottlieb said the approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of the regulator’s longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.
“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. The path to developing generic drug-device combination products like this one is challenging,” Gottlieb said.
EpiPen aims to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction.
The FDA said it has approved various epinephrine auto-injectors under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, ‘authorized generic’ versions of EpiPen and Adrenaclick are sold without the brand names.
An authorized generic is produced under the brand’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand.
However, the labeling or packaging is changed to remove the brand name. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.
Epinephrine auto-injector products are known as combination products as they feature a drug (epinephrine) and a device (the auto-injector). Development of such generic products can be more challenging than regular drug products and the FDA regularly takes steps to help guide industry through the process.
