The FDA Finally Approved a Generic EpiPen Product—But a Shortage Looms Ahead of the School Year
Could EpiPen shortages be a thing of the past now that there's a generic product?
The Food and Drug Administration (FDA) on Thursday followed through on a long-standing mission to approve an EpiPen generic made 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.
The introduction of a generic EpiPen to consumers could provide some financial relief to customers who have complained about the products’ skyrocketing prices over the last decade. Bu an ongoing EpiPen shortage ahead of the 2018-2019 school year could influence prices immediately, 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.
Does your family struggle with food allergies? Read on:
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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.