According to Sunovion, the FDA has issued a complete response letter (CRL) for its NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD.
Sunovion submitted the NDA for SUN-101/eFlow in July 2016, and the FDA accepted the application in October 2016, giving a PDUFA date of May 29, 2017.
In response to the CRL, Sunovion said that it would discuss a way forward with the FDA and added, “We are confident in SUN-101/eFlow and are committed to bringing this innovative therapy to COPD patients in the US as quickly as possible.”
The company said that the CRL did not contain a requirement for additional clinical studies in order for SUN-101/eFlow to be approved.
Read the Sunovion press release.
