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Intarcia Therapeutics, Inc.

http://www.intarcia.com

Latest From Intarcia Therapeutics, Inc.

Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements

Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.

Drug Review Drug Approval Standards

Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Complete Response Letters

Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication

Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.

Complete Response Letters Drug Approval Standards

US FDA Continues Shutout Of Companies Seeking Drug Rejection Hearings

Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.

Complete Response Letters Drug Review
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Medical Devices
    • Implantable Devices
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • BioMedicines, Inc.
    • PhaseGain Clinical Research, Inc.
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