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Purdue Pharma LP

www.purduepharma.com

Latest From Purdue Pharma LP

‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.

Advisory Committees Drug Safety

‘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
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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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