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Mylan's EpiPen Boosted as FDA Sees Holes in Teva Application

  • Teva expects its injection will be `significantly delayed'
  • Israel drugmaker will submit response to U.S. agency
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Mylan NV may be able to curtail a decline in future sales of its EpiPen allergy-reaction injector after the U.S. Food and Drug Administration identified “major deficiencies” in an application for a competing generic version from Teva Pharmaceutical Industries Ltd.

Teva intends to submit a response to the FDA, but expects the launch of its epinephrine injection to be “significantly delayed” until at least 2017, the company said in a filing to the Tel Aviv stock exchange Tuesday.