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Macugen Approval History

  • FDA approved: Yes (First approved December 17th, 2004)
  • Brand name: Macugen
  • Generic name: pegaptanib
  • Dosage form: Ophthalmic Injection
  • Company: Eyetech / Pfizer Inc
  • Treatment for: Macular Degeneration

Macugen (pegaptanib) is a selective vascular endothelial growth factor (VEGF) antagonist indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision.

Development History and FDA Approval Process for Macugen

Dec 17, 2004Approval Macugen Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration
Aug 27, 2004FDA Advisory Committee Reviews Clinical Data of Eyetech/Pfizer Priority 1 NDA Submission for Macugen, an Investigational Treatment for Neovascular AMD
Aug 18, 2004Eyetech/Pfizer Announce FDA Acceptance of the New Drug Application for Macugen (pegaptanib sodium injection)
Jun 17, 2004Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration
May 26, 2004FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection)

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