FDA Approves 1st Generic EpiPenLast Updated: August 16, 2018.
THURSDAY, Aug. 16, 2018 (HealthDay News) -- The first generic version of the EpiPen was approved by the U.S. Food and Drug Administration on Thursday, paving the way for more affordable versions of the lifesaving allergy emergency medication.
Though other injectors are available, this drug, made by Teva Pharmaceuticals USA, is the first the FDA has said is the equivalent of the EpiPen. It can be automatically substituted for EpiPen in pharmacies across the United States, the Washington Post reported.
With a new school season about to start, people have been reporting a shortage of EpiPens, the newspaper noted.
"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 Dr. Scott Gottlieb said in an agency news release.
"This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," Gottlieb added.
The price of the drug and its launch date were not yet available, but the company's statement suggested it would not be in time for many parents who are scrambling to find EpiPens in their pharmacies now, the newspaper reported. Teva will market its generic epinephrine auto-injector in 0.3 milligram (mg) and 0.15 mg strengths.
EpiPen, made by Mylan, injects the hormone epinephrine into the thigh to reverse potentially fatal reactions to bee stings, peanuts and other allergens.
Although the key ingredient is cheap and the EpiPen was first approved in 1987, Mylan began increasing the price of the product, from less than $100 for a pack of two injectors in 2007 to $608 for a pair now. In response to criticism over the price of its drug, EpiPen introduced its own half-priced generic in 2016, the Post reported.
SOURCES: Aug. 16, 2018, news release, U.S. Food and Drug Administration; Washington Post
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