FDA Approves First Ever Generic EpiPen in the United States
On Thursday, federal regulators approved the country’s first generic competitor to the EpiPen, which can now potentially lead the way of lowering costs for this medical device.
The Food and Drug Administration approved Teva Pharmaceutical Industries Ltd’s generic version of Mylan NV’s EpiPen and EpiPenJr.
According to Business Insider, FDA Commissioner Scott Gottlieb stated, “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.”
Over the last few years, Mylan has also faced a lot of controversy, due to the company drastically hiking the price more than 400 percent in less than a decade. The price has risen from less than $100 in 2007 for a pack of two injectors to just over $600. Mylan has also been facing supply issues. The FDA earlier this year announced a shortage of EpiPens.
Teva said in a statement today “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market.”