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# Vernalis Gets ‘Complete Response’ on Rx Cough-Cold NDA
- URL: https://www.fdaweb.com/vernalis-gets-complete-response-on-rx-cough-cold-nda/
- Published: 2017-08-07T12:00:00.000Z
- Updated: 2026-09-14T22:39:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139317

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](https://www.fdaweb.com/fda-issues-a-complete-response-letter-on-vernalis-nda/)).

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.