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ApoPharma Inc.

Division of Apotex Inc.

Latest From ApoPharma Inc.

FDA Approving More Novel Drugs Without Advisory Committee Review

The Center for Drug Evaluation and Research is becoming more comfortable approving new molecular entities and novel biologics without first seeking the views of its outside experts. In 2011, 13 of the 30 novel therapeutics cleared did not undergo advisory committee scrutiny beforehand.

BioPharmaceutical United States

FDA’s Banner Year for Drug Approvals: Time to Change the Focus

FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.

BioPharmaceutical Drug Approval Standards

Another Vote for Accelerated Approval

The Oncologic Drugs Advisory Committee review of ApoPharma’s Ferriprox was not one of the highest profile meetings of the past year. But for sponsors concerned about the availability of the accelerated approval pathway, it was a very important event.

BioPharmaceutical Advisory Committees
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Dermatology
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • Canada
  • Parent & Subsidiaries
  • Apotex Inc.
  • Senior Management
  • Michael Spino, Pres.
  • Contact Info
  • ApoPharma Inc.
    Phone: (416) 741-4256
    150 Signet Dr.
    Toronto, M9L 1T9