Chlorphenamine/codeine - Vernalis

Drug Profile

Chlorphenamine/codeine - Vernalis

Alternative Names: CCP-01; Chlorphenamine polistirex/codeine polistirex; Codeine polistirex/chlorphenamine polistirex; Codeine/chlorphenamine; Tuzistra XR

Latest Information Update: 09 Sep 2015

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At a glance

  • Originator Vernalis
  • Developer Tris Pharma; Vernalis
  • Class Antitussives; Morphinans; Opioid analgesics; Sedating antihistamines
  • Mechanism of Action Histamine H1 receptor antagonists; Opioid mu receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Common cold; Cough

Most Recent Events

  • 08 Sep 2015 Launched for Cough and Common cold in USA - first global launch (PO)
  • 30 Apr 2015 Registered for Cough and Common cold in USA - First global approval (PO)
  • 15 Sep 2014 PDUFA action date of 30 April 2015 assigned by FDA for chlorphenamine/codeine for common cold/cough
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