Mylan Specialty LP contends that Teva Pharmaceuticals USA Inc.’s generic epinephrine auto-injector differs in design and operation from Mylan’s EpiPen and should not be approved until Teva conducts comparative performance tests and is evaluated at a joint meeting of several FDA advisory committees.
In a citizen petition to FDA, Mylan Specialty, a subsidiary of Mylan NV, asks the agency not to approve Teva’s ANDA unless it finds that patients and...
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