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Qutenza Approval History

FDA Approved: Yes (First approved November 16, 2009)
Brand name: Qutenza
Generic name: capsaicin
Dosage form: Transdermal Patch
Previous Name: NGX-4010
Company: NeurogesX, Inc.
Treatment for: Postherpetic Neuralgia

Qutenza, formerly NGX-4010, is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.

Development History and FDA Approval Process for Qutenza

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

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