FDA approves first generic EpiPen

The new generic version was approved after outrage over the high cost of EpiPen.

August 16, 2018, 2:14 PM

The U.S. Food and Drug Administration has approved the first generic version of the EpiPen and EpiPen Jr auto injector for the emergency treatment of allergic reactions.

The approval is part of the FDA's "longstanding commitment" to providing access to low-cost generic alternatives, FDA Commissioner Scott Gottlieb said in a statement.

"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," the commissioner said.

It is unclear how much the generic product -- manufactured by Teva Pharmaceuticals -- will cost. In August 2016, Mylan Pharmaceuticals was criticized for raising the price of a two-pack of EpiPens to $600.

The price of two EpiPens was about $100 in 2009. The brand name version is by far the most popular epinephrine auto-injector on the market.

The generic version of "the most widely-prescribed epinephrine auto-injector in the U.S." has been approved for adults and children who weigh more than 33 pounds, Gottlieb said. It can be used to treat life-threatening allergic reactions from insect bites or stings, food medications, latex and other causes, according to the FDA.

The generic auto-injector is also intended for immediate administration of epinephrine, which works by reducing swelling in the airway and increasing blood flow in the veins.

"Combination products," such as epinephrine auto-injectors that include both a drug and a device, are "more challenging than typical drug products" to develop generic versions, according to the FDA.

Complex products are "hard to copy" and often take a long time, Gottlieb said, adding that the FDA is working on more efficient ways to develop generic products.

"We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications," he said.

An "authorized generic" is made using the brand name's existing new drug application and uses the same formulation, process and manufacturing facilities used by the brand name manufacturer, according to the FDA. The label and packaging used by the brand name are also changed.