Teva expects FDA preapproval inspection of troubled Celltrion plant this year

Teva said in its first-quarter earnings report that it expects an FDA pre-approval inspection in the coming months of the plant where its partner Celltrion produces the API for Teva's migraine treatment fremanezumab. Wall Street speculation had focused on the fremanezumab approval and rollout to happen next year because of regulatory issues with the manufacturer, but Teva said in its earnings report that while it doesn’t expect a sign-off for the drug by the agency by mid-June, it does foresee getting approval for a launch by the end of 2018. “We do not expect to receive FDA approval on our Biologics License Applications (BLA) for fremanezumab on the mid-June PDUFA date.” Teva CEO Kare Schultz said in a Q1 2018 call after reporting earnings that beat Wall Street estimates. But Schultz said Teva does expect FDA approval this year.