U.S. FDA approves first generic of Mylan's EpiPen
U.S. health regulators on Thursday approved Teva Pharmaceutical Industries Ltd`s generic of Mylan NV`s EpiPen, making it the first copycat version of the life-saving allergy treatment.
U.S.-listed shares of Teva jumped 6 percent to $23.88, while Mylan shares were down 0.64 percent.
Mylan had come under intense regulatory and political scrutiny in the last few years due to escalating price of EpiPen amid lack of competition.
EpiPen is intended to automatically inject a dose of epinephrine, also known as adrenaline, into a person`s thigh to stop an allergic reaction.
"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 Scott Gottlieb said.
The U.S. Food and Drug Administration has approved several epinephrine auto-injectors, including Adrenaclick and Auvi-Q.
In addition, "authorized generic" versions of EpiPen and Adrenaclick are already in the market.
Mylan`s revenue from EpiPen has dropped sharply over the last year due to increased competition and the launch of its own cheaper generic.
(This article has not been edited by Zeebiz editorial team and is auto-generated from an agency feed.)
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