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Metvixia Approval History

  • FDA approved: Yes (First approved July 27th, 2004)
  • Brand name: Metvixia
  • Generic name: methyl aminolevulinate hydrochloride
  • Dosage form: Cream
  • Company: PhotoCure ASA
  • Treatment for: Keratosis

Metvixia (methyl aminolevulinate hydrochloride) is a porphyrin precursor used in combination with the Aktilite CL128 lamp for treatment of actinic keratoses.

Development History and FDA Approval Process for Metvixia

Jun 27, 2008Approval Photocure Receives FDA Approval for Metvixia/Aktilite Photodynamic Therapy
Jul 27, 2004Approval FDA Approves Metvixia for Actinic Keratosis
Jun 17, 2004U.S. New Drug Application Approval Expected for Metvix

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