Generic EpiPen cleared by FDA as Teva challenges Mylan

Mylan’s EpiPen, the life-saving and costly allergy treatment, will soon face a generic rival, a first in more than two decades on the market. The Food and Drug Administration on Thursday cleared Teva Pharmaceutical Industries to start selling generic versions EpiPen and EpiPen Jr., years after the Israeli drugmaker requested it.

The products are the first generic treatments that compete directly with EpiPen, whose price has soared more than 400 percent in the past decade, and that can be used to replace the brand-name version.

Since acquiring the rights to EpiPen in 2007, when a dose cost about $57, Mylan sparked public furor two years ago by hiking the cost of EpiPen to $600 for a two-pack of the auto-injecting pens. After drawing fire from patients and politicians, Mylan offered a generic version of its device for about half the price.

“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 product against drug shortages,” FDA Commissioner Scott Gottlieb said in a news release.

The regulatory clearance comes as children prepare to return to school, a time when EpiPen sales typically jump as parents stockpile injectors.

The FDA in May added the EpiPen to its tally of drugs in short supply. Hundreds of patients across the country reported trouble getting prescriptions filled due to manufacturing issues at a Pfizer factory that makes the devices in partnership with Mylan.

The drug agency in 2016 declined to approve Teva’s generic EpiPen, before its escalating cost hit the news.

Mylan had a $1 billion in brand-name EpiPen sales that year, but that figure fell by more than half in 2017 as its generic version eroded brand-name sales.

On Thursday afternoon, Mylan shares fell 0.2 percent, while those of Teva increased 6.8 percent.