MS therapeutics: 1 withdrawal, 1 setback
March 5, 2018…ical pharmacology sections of the application were insufficient to allow a complete review. Celgene will meet with FDA officials to discuss what additional information is needed, but the setback is expected to significantly delay the launch of ozanimod. The drug was expected to obtain approval in late 2018/early 2019, but that will likely be delayed at least 9-12 months. As a result, ozanimod is now expected to be launched in the U.S. after generi…