FDA Approves First Generic EpiPen

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FDA Approves First Generic EpiPen

VOA News

For those who suffer from severe allergic reactions to foods, insect stings, and medications, having an EpiPen can save their lives.

As reported by the Wall Street Journal, an estimated 3.6 million Americans were prescribed an EpiPen in 2015, and they're not exactly cheap to own.

While that fact may seem trivial to those who don't need the life-saving medicine, everyone should be concerned that Mylan, the maker of the EpiPen, raised their prices by an extravagant amount since 2009.

After the backlash of the Mylan's decision to up their prices to $600 for a pack of two (which were previously marked at $57), the company launched its own generic, a lower-cost version for $300.

To make matters worse, been a major shortage of the product due to "to a supply and manufacturer issues."

The Food and Drug Administration (FDA) announced the shortage in May, and as of August 8, the problem has yet to be resolved.

"You're playing this awful roulette with your kid's life," Jim Davis told Chron, adding that he has an eight-year-old daughter with a peanut allergy.

Fortunately, the FDA has given its approval to Teva Pharmaceuticals' generic Epipen, which can be substituted by pharmacists, even if doctors choose to prescribe the original brand.

"Today's 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," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

"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."

Although Teva has yet to announce how much they'll charge, a spokesperson for the manufacture said it'll cost "as much as 80 percent lower" compared to the EpiPen's price tag.

They also added their generic version will hit the market "in the coming months."

Following the FDA's stamp of approval, the federal agency is looking to authorize more generic auto-injectors in the market to "remove barriers to generic development and market entry of critically important medicines."

"We're advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we're prioritizing review of many complex generic drug applications," Gottlieb said.

What do you think about the FDA's approval on the new generic EpiPen? Let us know in the comments!


Maya has been working at Shared for a year. She just begrudgingly spent $200 on a gym membership. Contact her at maya@shared.com