Teva on Thursday announced that it received FDA approval to launch a generic version of Mylan's EpiPen (epinephrine) auto-injector for the emergency treatment of allergic reactions, including anaphylaxis, in adults and paediatric patients. FDA Commissioner Scott Gottlieb said "today's approval of the first generic version of the most widely prescribed epinephrine auto-injector in the US 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."
Teva stated "we're applying our full resources to this important launch in the coming months and [are] eager to being supplying the market." The drugmaker did not provide details regarding timing of the launch or price of the therapy.
In 2016, the FDA issued Teva a complete response letter regarding its filing for generic EpiPen, citing "major deficiencies" in the marketing application, with the company later indicating that US approval could occur by late 2017 or early 2018. Last year, the FDA unveiled several initiatives aimed at accelerating the development and availability of complex generics.
Mylan launched an authorised generic version of EpiPen in 2016, for $300 per pack of two pens, in response to scrutiny over the branded drug's rising price. The company also provided discounts to reduce patient costs for the branded version of the treatment.
Meanwhile, Kaléo re-launched its Auvi-Q (epinephrine) auto-injector last year after the treatment was previously removed from the market due to issues with the injection mechanism. Kaléo said at the time that its product would be made available under an access scheme that would provide Auvi-Q at no cost out-of-pocket to patients with commercial insurance. In addition, CVS Health reached a deal to provide Impax Laboratories' authorised generic for Adrenaclick (epinephrine) at a cash price of $110 per two-pack.
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