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Cardiome Pharma Corp.

www.cardiome.com

Latest From Cardiome Pharma Corp.

Keeping Track Of The US FDA's Final Novel Approvals, CRLs Of 2019

The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug

Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing  clinical hold on the drug before the company can do any further study in humans.
Advisory Committees Cardiovascular

Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.

Advisory Committees Cardiovascular

A Year Of Reconsiderations For US FDA Advisory Committees

Correvio’s anti-arrhythmic vernakalant is returning to an advisory committee a dozen years after its first review, continuing a recent pattern of return visits for applications – and 12 years isn’t even close to the longest long back for US FDA panel in 2019.

Advisory Committees Drug Review
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Therapeutic Areas
  • Cardiovascular
  • Infectious & Viral Diseases
  • Alias(es)
  • Nortran Pharmaceuticals Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • Canada
  • Parent & Subsidiaries
  • Cardiome Pharma Corp.
  • Senior Management
  • William Hunter, MD, Pres. & CEO
    Justin A Renz, CFO
    Sheila Grant, COO
    Hugues Sachot, Chief Commercial Officer
  • Contact Info
  • Cardiome Pharma Corp.
    Phone: (604) 677-6905
    1441 Creekside Dr., 6th Fl.
    Suite 405
    Vancouver, V6J 4S7
    Canada
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