Pivotal single-dose pharmacokinetic study of CCP-08 in patients with cough cold
Phase of Trial: Phase I
Latest Information Update: 07 Aug 2017
At a glance
- Drugs CCP 08 (Primary)
- Indications Common cold; Cough
- Focus Pharmacokinetics
- Sponsors Vernalis
- 07 Aug 2017 According to a Vernalis media release, the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-08, FDA identified outstanding items that need to be addressed prior to the resubmission and approval of the NDA.
- 21 Dec 2016 According to a Vernalis media release, the U.S. Food and Drug Administration has accepted the CCP-08 New Drug Application ("NDA") for full review. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date for conclusion of its review of 4 August 2017.
- 13 Apr 2016 According to a Vernalis media release, status changed from planning to completed.