Teva suffers setback over EpiPen generic

3 March 2016

Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) has suffered a serious blow to its plans to launch a generic version of Mylan’s (Nasdaq: MYL) EpiPen (epinephrine) auto-injector in the USA.

The Food and Drug Administration (FDA) found “major deficiencies” in Teva’s application and the company admitted a significant delay was now inevitable.

A spokesman said: "Teva received a complete response letter on February 23 relating to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017."

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