FDA rejects Sunovion new drug app for COPD drug and nebulizer

An FDA CRL for the COPD therapy SUN-101 and the Eflow nebulizer used to deliver it is sending Sunovion Pharmaceuticals Inc. back into talks with the agency and pushing out the potential realization of up to $210 million in commercial milestones for former backers of Elevation Pharmaceuticals Inc., from which Sunovion acquired the program in 2012.