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The FDA Finally Approved an EpiPen Generic. But a Shortage Looms Ahead of the School Year

The Food and Drug Administration (FDA) on Thursday followed through on a long-standing mission to approve an EpiPen generic manufactured by Teva Pharmaceuticals. Teva stock jumped 7.3% in Thursday trading following the news that it will be the first company to market generics of Mylan’s popular EpiPen and EpiPen Jr. auto-injectors, life-saving epinephrine devices that can treat deadly reactions to severe food allergies.

But, while the introduction of a generic EpiPen to the market could theoretically provide some financial relief to customers who have complained about the products’ skyrocketing prices over the last decade, there’s still a fly in the ointment: An ongoing EpiPen shortage ahead of the 2018-2019 school year, which has already begun for a sizable swath of the country.

Regulators themselves alluded to the shortages on Thursday. “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,” said FDA Commissioner Scott Gottlieb in a statement announcing the 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.”

Mylan’s brand name EpiPen, its own “authorized generic” version of the product, and competitor Impax Laboratories’ Adrenaclick are all currently in shortage or available in limited supply due to high demand and manufacturing delays.

The EpiPen shortage partially stems from supply chain breakdowns involving Meridian Medical Technologies, a unit of pharmaceutical giant Pfizer, which is facing widespread manufacturing issues that have put the squeeze on hundreds of essential medications, as my colleague Erika Fry reported earlier this year.

An EpiPen competitor from Kaleo called AUVI-Q is not currently in shortage, but does come with different dosing and operation instructions from the EpiPen.

“We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” Teva said in a statement without providing pricing details.

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