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Alkermes PLC

www.alkermes.com

Latest From Alkermes PLC

Rescinding A Refuse-To-File: A Precedent Of Sorts

US FDA’s decision to rescind refuse-to-file letter for Alkermes’ high-profile depression drug is extremely unusual – but not literally unprecedented. One prior example of rescinding an RTF involves an ANDA.

Drug Review Drug Approval Standards

Alkermes Refuse-To-File Reversal: Is It Really Good News For Anyone?

US FDA’s decision to 'un-refuse' ALKS 5461 was made within same review office that was caught up in the Sarepta controversy – albeit in a different division. What does the RTF reversal mean for Alkermes and for the agency?
Drug Review Drug Approval Standards

Refusal Reversal: Alkermes Review Back On Track, But Could Still Be Bumpy

US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.

Drug Review Drug Approval Standards

FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval

Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.

Drug Review Neurology
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Company Information

  • Industry
  • Biotechnology
    • Large Molecule
    • Nanotechnology, Chips, etc.
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Macromolecule
      • Pulmonary
  • Therapeutic Areas
  • Cancer
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Alias(es)
  • Alkermes Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Ireland
  • Parent & Subsidiaries
  • Alkermes PLC
  • Senior Management
  • Richard F Pops, Chmn. & CEO
    James M Frates, SVP, CFO
    Elliot W Ehrich, MD, EVP, R&D
    Blair C Jackson, SVP, Bus. Dev.
    Mark Stejbach, SVP, Chief Commercial Officer
    James Robinson, Pres. & COO
  • Contact Info
  • Alkermes PLC
    Phone: 1 772 8000
    1 Burlington Rd.
    Connaught House
    Dublin 4, MA
    Ireland
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