Vernalis Gets ‘Complete Response’ on Rx Cough-Cold NDA

FDA has issued Vernalis a complete response letter (CRL) on its NDA for CCP-08, an undisclosed extended-release product being developed for Vernalis by Tris Pharma for the U.S. prescription cough-cold market. A CRL was issued to Vernalis for another undisclosed product in April (see story).

The latest CRL “indicated that the outstanding items which resulted in the CRL for CCP-07 remain and that they need to be addressed prior to the resubmission and approval of both NDAs,” the company says. “Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08.”

CCP-08 is the third extended-release product being developed for Vernalis by Tris Pharma for the prescription cough-cold market. The first product, Tuzistra XR was approved by FDA in 4/2015 and was launched by Vernalis in 9/2015.