Generic EpiPen poised to alleviate shortages

August 21, 2018

While FDA approved the first generic version of epinephrine (EpiPen and EpiPen Jr, Mylan), the new product is not yet on the market.

FDA approved the first generic version of epinephrine (EpiPen and EpiPen Jr, Mylan), which may help alleviate the current shortage of EpiPen in certain areas of the United States.

Teva gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. However, a company spokeswoman declined to say when it would be available or how much it would cost, The New York Times reported.

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Meanwhile, FDA is taking steps to alleviate EpiPen’s limited availability in certain areas. The agency extended the expiration date of specific lots of 0.3 milligram EpiPens products marketed by Mylan by 4 months beyond the labeled expiration date.

“FDA continues to work closely with Mylan on EpiPen production and supply, and also has been in contact with the other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply as the school year begins since this is historically accompanied by increased product demand,” the agency said in a statement.

Meanwhile, FDA’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,” said FDA Commissioner Scott Gottlieb, MD, in a statement from FDA. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”

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In 2016, Mylan came under fire after the price of EpiPen spiked from around $100 in 2008 to between $500 and $600. Then, Mylan offered discounts and said would offer the first generic version of EpiPen for around $300 per 2-pack.

FDA said that there are “authorized generic” versions of EpiPen and Adrenaclick, which are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process, and manufacturing facilities that are used by the brand-name manufacturer.

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