Af­ter a years-long de­lay, FDA ap­proves first gener­ic ver­sions of EpiPen

The FDA on Thurs­day ap­proved Te­va Phar­ma­ceu­ti­cals’ first gener­ic ver­sion of EpiPen and EpiPen Jr (ep­i­neph­rine) au­to-in­jec­tor for the emer­gency treat­ment of al­ler­gic re­ac­tions, in­clud­ing those that are life-threat­en­ing  in adults and chil­dren weigh­ing more than 33 pounds.

The ap­proval comes as the US has grap­pled with short­ages of EpiPens fol­low­ing reg­u­la­to­ry de­lays in get­ting a gener­ic on the mar­ket. In the last decade, the price of EpiPens have shot up more than 400%. This new ap­proval means Te­va can mar­ket its gener­ic, sub­sti­tute ep­i­neph­rine au­to-in­jec­tor in 0.3 mg and 0.15 mg strengths.

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