In February, the FDA failed to approve Teva’s drug application for the generic device, pointing out “major deficiencies.”
At the time, Teva requested a meeting with the agency but did not hear back. However, after “the media attention in the last few weeks, the FDA has come back to us and we will have a meeting very, very quickly,” Sigurdur Olafsson, Teva’s head of global generic global medicine, said in a webcast.
While analysts expected Teva to change the design of its auto-injector device to address the FDA’s concerns with dosing issues, Mr. Olafsson said the company is not planning any device modifications.
Mylan lacks any major competition for its EpiPens and holds an estimated 94 percent market share in the U.S., according to the report. If approved and priced lower than the EpiPen, Teva’s epinephrine auto-injector could impact a significant part of Mylan’s market share, according to Wall Street analysts.
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