FDA Agrees to New Review of the SUN-101/e-Flow COPD Treatment System
U.S. regulators have agreed to Sunovion Pharmaceuticals’ request for another review of its SUN-101/e-Flow system for treating chronic obstructive pulmonary disease. The review will cover a New Drug Application that Sunovion resubmitted after the Federal Drug Administration decided the company did not have to conduct additional clinical trials of SUN-101/e-Flow’s safety and effectiveness.