www.fdanews.com/articles/175618-fda-issues-complete-response-letter-to-teva-for-epinephrine-anda
FDA Issues Complete Response Letter to Teva for Epinephrine ANDA
March 7, 2016
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.