First Generic EpiPen Approved By FDA

On Thursday, the Food and Drug Administration (FDA) approved the first generic version of the EpiPen from Teva Pharmaceuticals. The name brand version from Mylan made headlines in recent years after a dramatic price increase of over 400 percent in less than a decade.

According to a report from the Washinton Post, the generic version of the lifesaving device can be automatically substituted for prescriptions for an EpiPen or EpiPen Jr. The news comes just in time for parents who may be replacing the injectable medication for sudden allergic reactions to keep at schools or for their personal use. Other devices with epinephrine include Adrenaclick and Auvi-Q, but pharmacists are not able to directly substitute them for EpiPen prescriptions, according to a CNBC report.

“We’re applying our full resources to this important launch in the coming months and [are] eager to begin supplying the market,” Teva said in a statement. Recently the company experienced a manufacturer problem, which could make it difficult to get new prescriptions filled at the moment.

Today, the cost of a two pack of EpiPen injectors runs about $608, but just over a decade ago, the cost for the two pack was less than $100. Although the device first gained approval in 1987, the price has risen out of reach for many families who rely on the epinephrine for life-threatening acute allergic reactions. Mylan has been accused in a lawsuit by Sanofi of attempting to gain a monopoly in the market. Also, Mylan settled a Department of Justice lawsuit for $465 million. The concern was that the company overcharged Medicaid for the drug.

Despite opposition from Mylan over the new generic, the FDA finally approved the device, which was challenging to produce. The Teva brand will compete with Mylan’s EpiPen generic, which it introduced in 2016, and it costs half the price of the company’s name brand version at $300. There’s no exact word on what the cost of the Teva generic might cost.

“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,” FDA Commissioner Scott Gottlieb said in a statement.

Overall, another option for people who suffer from allergies and need an instant choice for an acute reaction means that this generic approval is a big win. The Trump administration also counts it as a win since President Donald Trump promised lower cost medications.

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