FDA Issues Complete Response Letter to Teva for Epinephrine ANDA

The FDA has issued a complete response letter to Israel-based Teva Pharmaceuticals for its generic epinephrine ANDA.

Teva said in a recent SEC filing that it is evaluating the CRL and intends to submit a response.

The company anticipates that its epinephrine product will be “significantly delayed and that any launch will not take place before 2017,” the filing states.