Teva’s Generic EpiPen Gets Green Light For US Market

The US Food and Drug Administration (FDA) has granted its approval to Israel’s Teva Pharmaceutical Industries to begin marketing in the US its generic version of the EpiPen, a branded treatment by US pharmaceutical company Mylan for severe and life-threatening allergic reactions, also known as anaphylactic shock

The move comes two years after Mylan drew widespread criticism for a price hike of the epinephrine auto-injector to some $600 in 2016 for a two-pack, up from $100 for two almost a decade prior. Amid the outrage, Mylan released a generic version of its own EpiPen for about $300 two years ago. Mylan bought the rights to the EpiPen in 2007 from Merck KGaA and gradually raised the price.

FDA Commissioner Scott Gottlieb told AFP that the “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 said in a statement: “We have received us approval for our generic version of the EpiPen injectable (epinephrine injection OSP) in 0.3 and 0.15 mg dosages, representing an important step in providing more prescription treatments for our patients that meet the FDA’s rigorous standards.”

“We will allocate maximum resources in the coming months and expect to bring this product to market. With its launch, Teva’s generic product will be EpiPen’s only generic version,” the company added.

Following the announcement last week, Teva’s shares rose approximately seven percent.