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