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Qutenza FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved November 16, 2009)
Brand name: Qutenza
Generic name: capsaicin
Dosage form: Transdermal Patch
Company: Averitas Pharma, Inc.
Treatment for: Neuropathic Pain, Postherpetic Neuralgia, Diabetic Peripheral Neuropathy

Qutenza (capsaicin) is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

  • Capsaicin contained in Qutenza can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin. Qutenza must be administered only by a healthcare provider.
  • Qutenza patches are applied for 60 minutes for the treatment of PHN, and 30 minutes for DPN of the feet. Treatment can be repeated no more frequently than every three months.
  • Common adverse reactions include application site erythema, application site pain, and application site pruritus.

Development timeline for Qutenza

Jul 21, 2020Approval Averitas Pharma Announces FDA Approval of Qutenza for the Treatment of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy of the Feet
Nov 16, 2009Approval NeurogesX Receives FDA Approval of Qutenza (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
Aug  6, 2009NeurogesX Announces New PDUFA Date for Qutenza New Drug Application
Jun 10, 2009NeurogesX Provides U.S. Regulatory Update for Qutenza
Dec 19, 2008NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia
Oct 22, 2008NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.