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Purdue Pharma LP

www.purduepharma.com

Latest From Purdue Pharma LP

One Loss, One Tie: US FDA Panels Prove Difficult For Opioid Sponsors Intellipharmaceutics, Esteve

Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.

Advisory Committees Drug Review

US FDA's Decade In Review: From Biosimilars To Real-World Evidence

A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.

FDA Biosimilars

Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim

Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.

Advisory Committees Drug Review

The FDA Builds On Lessons Learned In Rebuilding Quality Metrics Program

US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.

Manufacturing Quality
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
    • Nutraceuticals
    • OTC, Consumer
  • Therapeutic Areas
  • Gastrointestinal
  • Infectious & Viral Diseases
  • Inflammation
  • Neurology, Nervous System
  • Alias(es)
  • Purdue Frederick Co.-Purdue Pharma LP
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Purdue Pharma LP
  • Senior Management
  • Craig Landau, Pres. & CEO
    Jean-Jacques Charhon, CFO
    Saeed Motahari, SVP, Chief Commercial Officer
    Alan Dunton, MD, Head, R&D
    Marcelo Bigal, MD, PhD, CMO
    Julie Ducharme, PhD, VP, CSO
  • Contact Info
  • Purdue Pharma LP
    Phone: (203) 588-8000
    201 Tresser Blvd.
    Stamford, CT 06901
    USA
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