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Braeburn Pharmaceuticals Inc.

Latest From Braeburn Pharmaceuticals Inc.

US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

Legal Issues FDA

US FDA, Advisory Committees Rarely Disagree

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
Advisory Committees Approvals

Blocked By Sublocade: Braeburn Sues To Get Brixadi Buprenorphine Formulation Onto Market

Lawsuit against US FDA challenges scope of three-year exclusivity awarded to Indivior’s Sublocade, the first monthly depot formulation of buprenorphine for treating opioid use disorder.

Legal Issues Neurology

US FDA’s Transfer Policy For Orphan Drug Designation Under Scrutiny

Braeburn Pharmaceuticals says awarding Indivior’s opioid use disorder treatment Sublocade seven-year orphan exclusivity that flows from a 1994 orphan drug designation for Subutex would be an abuse of the system. The US FDA said it is carefully considering whether Sublocade qualifies for exclusivity ‘within the context of the opioid public health emergency.’

Rare Diseases FDA
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
    • Implantable Devices
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • AT Pharmaceuticals Inc.
  • Braeburn Pharmaceuticals SPRL
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Braeburn Pharmaceuticals Inc.
  • Senior Management
  • Michael M Derkacz, Pres. & CEO
    David J McIntyre, EVP, CFO & Treasurer
    Richard Malamut, MD, CMO
    Paul Johnson, Chief Commercial Officer
  • Contact Info
  • Braeburn Pharmaceuticals Inc.
    Phone: (609) 751-5375
    47 Hulfish St.,
    Suite 441
    Princeton, NJ 08542