US FDA Approves First Generic EpiPen

The United States Food and Drug Administration has just approved the very first generic competitor to the very popular EpiPen and EpiPen Jr emergency allergic-reaction treatment for adults (and children, respectively).  According to an announcement made this week, drug company Teva Pharmaceuticals gained their approvals to market the new generic drug.

In an emailed statement, Teva North America Commercial Executive Vice President Brendan O’Grady notes that this approval “marks an important step forward in bringing our patients additional prescription medications that have met the FDA’s rigorous standards.”

FDA Commissioner Scott Gottlieb comments, too, “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.”

This is important, of course, because EpiPen is the very popular brand-name epinephrine auto-injectors that, since its introduction to the market, has had no true competition.  Even its closest competitors—Adrenaclick and Auvi-Q—are not, generally, considered to be generics of EpiPen. As such, patients who need the EpiPen (those who have severe allergies to peanuts, for example) have not had an alternative to the quite expensive EpiPen injectors, a problem for those without insurance.

Perhaps more importantly, though, this may be quite the opportune time to introduce a generic since Pfizer (the maker of EpiPen, in partnership with Mylan) has been facing recent supply issues.

As such, Teva said, “We’re applying our full resources to this important launch in the coming months and eager to being supplying the market,” though they have not provided any details regarding release or pricing.

Finally, some consider the approval of this generic product to be quite a victory for the FDA at a time when the Trump administration is looking to deliver on a promise to deliver lower drug prices to American consumers. Indeed, as Gottlieb notes, “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.”

 

And upon releasing the news, Teva shares rose roughly 6 percent.

 

 

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