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NuPathe Inc.

Division of Teva Pharmaceutical Industries Ltd.
www.nupathe.com

Latest From NuPathe Inc.

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

Drug Review Profile Review Pathway

Teva Hits Pause On Business Development, Even As Some Deals Stumble

Teva CEO Erez Vigodman said the company will step away from business development for the “foreseeable future” while it digests the acquisition of Allergan’s generic drug business.

Deals Legal Issues

Zecuity Redesign Got Migraine Patch Through FDA, But Burning Continued

FDA worries about burning and scarring with the battery-powered Zecuity patch prompted NuPathe to reconfigure the drug-device combo; our Drug Review Profile shows how FDA thought the problem was solved, but adverse reaction reports soon after launch led to marketing suspension.

Drug Review Neurology

Teva Zecuity's Safety: Burns Go From Non-Issue In Label To Product Puller

Fate of migraine patch remains uncertian after 'large number' of patients suffer burns and scars; adverse event was issue during review of transdermal sumatriptan product, but didn't even make it into labeling; nine months later the problems have forced Teva to suspend marketing.

BioPharmaceutical United States
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
    • Implantable Devices
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Transdermal
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Teva Pharmaceutical Industries Ltd.
  • Senior Management
  • Armando Anido, CEO
    Mark W Pierce, MD, PhD, VP, CSO
    Jerry W McLaughlin, SVP & Chief Commercial Officer
  • Contact Info
  • NuPathe Inc.
    Phone: (610) 232-0800
    7 Great Valley Pkwy.
    Ste. 300
    Malvern, PA 19355
    USA
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