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Home » FDA Issues Complete Response Letter to Teva for Epinephrine ANDA
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.
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