FDA Approves First Generic Epi-Pen(TM) in Blow to Mylan

At long last, a potentially less expensive epinephrine auto-injector (EAI) device may be available to consumers very soon. TEVA Pharmaceuticals has received US government approval for a generic version of the Epi-PenTM originally made and marketed by Mylan Pharmaceuticals. Additional generic devices are on their way as well. The existing market for EAI devices is very large; different brands competing against each other could lead to lower prices. Our association fully supports any and all efforts aimed at better regulating healthcare costs for all Americans.

FDA Approves First Generic Epi-PenTM in Blow to Mylan

VibexTMAutoInjector 361x189 
TEVA Antares VibexTM epinephrine auto-injector device

FDA Approves TEVA Generic Version of the Epi-PenTM

By Nathan Bomey
Aug. 16, 2018

The EpiPen is getting a fresh dose of competition.

The Food and Drug Administration on Thursday approved what it described as the first official generic version of the EpiPen, a life-saving treatment for severe allergic reactions.

The generic device's seller, Teva Pharmaceuticals, is a rival to drug maker Mylan's brand-name version.

Mylan came under scrutiny in 2016 for a series of EpiPen price hikes. Soon after that, the company introduced what the FDA classifies as an "authorized generic" version of the EpiPen, which delivers an emergency injection of epinephrine to counteract anaphylaxis.

The Trump administration on Thursday described the go-ahead for Teva as reflective of its commitment to speeding up the pace of FDA approvals.

"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," FDA Commissioner Scott Gottlieb said in a statement.

Teva said the treatment's approval "marks an important step forward in bringing our patients additional prescription medications that have met the FDA’s rigorous standards. We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market."

A Mylan spokesperson was also not immediately available for comment. The company announced last week that it's considering a significant shift in corporate strategy that could ultimately lead to a sale.

Critics have cited Mylan as an example of exorbitant price increases that are becoming rampant in the pharmaceutical industry.

Mylan repeatedly defended its moves during the crisis but also introduced discounts and the authorized generic version. It also eventually agreed to a $465 million federal settlement after investigators concluded the drugmaker overcharged the government for the treatment.

The drug maker raised EpiPen prices by roughly 400% between 2010 and 2016, according to federal investigators.

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