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Pivotal single-dose pharmacokinetic study of CCP-08 in patients with cough cold

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Trial Profile

Pivotal single-dose pharmacokinetic study of CCP-08 in patients with cough cold

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Aug 2017

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At a glance

  • Drugs CCP 08 (Primary)
  • Indications Common cold; Cough
  • Focus Pharmacokinetics
  • Sponsors Vernalis

    • Most Recent Events

    • 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.

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