Teva suffers EpiPen generic setback after FDA rejection

pharmafile | March 4, 2016 | News story | Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection 

The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after the FDA rejected its version, flagging “major deficiencies”.

The Israeli-based company had originally planned to bring the auto-injector to market in 2017, but this no longer looks to be the case. EpiPen is used to treat anaphylaxis. It is a boost of adrenaline that helps to remedy a serious allergic reaction that is rapid in onset, and may cause death.

The firm issued a notice, stating: “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.”

This news, however, is expected to be a major boost for Mylan, which markets EpiPen in the US. Analysts had predicted that the company would lose out on $200m worth of sales to Teva when its generic was due to become available in 2017.

This is the second time in a few months that Mylan has received such a boost, after Sanofi’s rival product Auvi-Q was forced into a recall due to suspected device malfunctions.

Sean Murray

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