Teva Pharmaceuticals Wins FDA Approval for EpiPen; for Allergic Reactions

Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Last Thursday, the Food & Drug Administration 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.

Teva Pharmaceuticals has been given the green light to begin producing a generic version of the branded EpiPen and EpiPen Jr, according to a report on the Allergic Living web site.

This will be in addition to the authorized generic EpiPen that Mylan began marketing in 2016.

“The approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. 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,” said FDA Commissioner Scott Gottlieb, M.D.

He added that, “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 EpiPen is intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. 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” because they consist of a drug (epinephrine) and a device (the auto-injector). The development of generic combination products can be more challenging than typical drug products, and the FDA regularly takes steps to help guide industry through the process. The agency works with individual companies to support their development of such complex products, and creates publicly available guidance describing the steps the FDA recommends companies take to submit complete, approvable applications for various types of medical products. In this case, the FDA has published three draft or final guidances since 2009 related to the development of generic epinephrine auto-injectors. In addition, as with brand-name drugs, the FDA inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products.

This epinephrine injection (auto-injector) is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

“We’re applying our full resources to this important launch in the coming months and eager to being supplying the market,” Teva said in a statement. The company has not yet provided details on launch timing or the planned price.

By: Valerie Katif

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