FDA approves Teva’s generic EpiPen, rivaling Mylan version

By Health CareFOXBusiness

HHS Secretary on the EpiPen shortage

HHS Secretary Alex Azar on the EpiPen shortage, efforts to reduce drug prices and the opioid crisis.

The U.S. Food and Drug Administration (FDA) has approved the first generic EpiPen, granting Teva Pharmaceuticals permission to market its generic epinephrine auto injector, creating an alternative to Mylan Pharmaceuticals’ EpiPen.

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The life-saving medicine for those who have serious allergies, many of whom are children, has seen some controversy for its high price point, in some cases costing hundreds of dollars. Further, there are reports of an EpiPen shortage just ahead of critical back-to-school season.

According to the FDA, EpiPens are currently in shortage in select areas, which was first reported on May 9, 2018.

In a statement to FOX 8 News in Cleveland, the FDA said, "multiple factors have resulted in limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply disruptions and a manufacturer issue."  It stresses the companies have product available, but there may be "occasional spot outages." 

According to drugs.com, brand name EpiPen or EpiPen Jr. package (which contains 2 auto-injectors) will cost roughly $650, although there could be coupons available to lower the cost.

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Shares of Teva Pharmaceuticals were climbing on the news while Mylan shares were lower. Adamis Pharmaceuticals’ shares were lower. In July, Adamis was granted U.S. approval to sell an EpiPen rival. It will announce the pricing of the product in the second half of the year, according to Reuters.

Amneal Pharmaceuticals’ produces the generic auto-injector Adrenaclick. According to CVS, Adrenaclick can be purchaed for $109.99 for a two pack.