FDA issues Complete Response Letter for Sunovion’s New Drug Application to treat COPD patients

May 27 2017

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The CRL does not require Sunovion to conduct any additional clinical studies for the approval of SUN-101/eFlow.

Sunovion will work with the FDA to determine an appropriate path forward. We are confident in SUN-101/eFlow and are committed to bringing this innovative therapy to COPD patients in the U.S. as quickly as possible.