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The FDA Has Approved Teva’s Generic Version of the EpiPen

Some may consider it perfect timing that Teva was just given the green light by the Food and Drug Administration for its generic versions of both the EpiPen and EpiPen Jr.

This is after all the time of the year when children go back to school and those with life threatening allergies need to be protected.

Teva shares soared almost 6% on the news.

Teva’s products will be the first generic competitor to the EpiPen, made by Mylan. Mylan had also introduced its own authorized generic version back at the end of 2016.

While other versions of epinephrine auto-injectors are on the market, including the Adrenaclick and Auvi-Q, they are not considered EpiPen generics.

FDA Commissioner Scott Gottlieb stated, “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.”

“We’re applying our full resources to this important launch in the coming months and eager to being supplying the market,” Teva said in a statement. There was no statement on specific timing or any price.

Teva also said, “Today’s approval of our generic version of EpiPen(epinephrine injection, USP) Auto-Injector 0.3 mg and 0.15 mg in the US marks an important step forward in bringing patients additional prescription medications that have met the FDA’s rigorous standards.”

“Once launched, Teva’s product will be the only generic, AB-rated/therapeutically equivalent version of EpiPen.”

It was in early 2016 that Israel-based Teva had been rejected by the FDA for its generic EpiPen application.

According to the FDA, Teva’s generic products are expected to produce the same clinical effect and have the same safety profile as the EpiPen and EpiPen Jr. Though there are small differences in design, they will not affect safety or efficacy.

Mylan saw an approximately 63% drop in EpiPen sales between 2017 and 2016, according to Wells Fargo analyst David Maris.

“We believe there is pent-up demand,” Maris said.

Maris also said, “We’ve heard there are widespread shortages of EpiPen. “It’s clearly a headwind. And no one’s talking about how soon it will be cleared up,” he added.

Raymond James analysts believe Teva could control as much as a third of the approximate $750 million epinephrine market.

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