Antares Pharma Announces FDA Approval of Generic EpiPen Utilizing VIBEX Auto Injector

Antares Pharma (NASDAQ:ATRS) announced that the U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical, epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients. Our partner Teva filed an Abbreviated New Drug Application (ANDA) seeking FDA approval of the product as a generic substitute of Mylan’s branded product EpiPen.

As quoted in the press release:

“We are extremely pleased with the FDA’s decision to approve Teva’s ANDA for the first and only fully substitutable generic version of Mylan’s branded EpiPen, the most widely used epinephrine auto injector on the market,” said Robert F. Apple, President and Chief Executive Officer of Antares Pharma.  “This approval means patients living with severe, sometimes life-threatening allergic reactions, (anaphylaxis), who require immediate access to life-sparing epinephrine should have access to a generic alternative. We and our partner Teva worked diligently together to obtain the approval of this very complex drug/device rescue pen combination product utilizing our VIBEX auto injector platform and we look forward to Teva making it commercially available to patients.”

Antares previously entered into an exclusive License, Development and Supply Agreement with Teva for an epinephrine auto injector product to be marketed in the U.S.  Pursuant to the agreement, Antares is responsible for supply of the device which will be sold to Teva at cost plus margin.  Teva is responsible for commercialization and distribution of the final product for which Antares will receive royalties on net sales.

Click here to read the full press release.