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Purdue Pharma LP

www.purduepharma.com

Latest From Purdue Pharma LP

‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

Real-World Evidence Neurology

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
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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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