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AzaSite Approval History

  • FDA approved: Yes (First approved April 27th, 2007)
  • Brand name: AzaSite
  • Generic name: azithromycin
  • Dosage form: Ophthalmic Solution
  • Company: InSite Vision Incorporated
  • Treatment for: Conjunctivitis, Bacterial

AzaSite is an ophthalmic formulation of the well-known, broad-spectrum antibiotic azithromycin indicated for the treatment of bacterial conjunctivitis.

Development History and FDA Approval Process for AzaSite

Apr 29, 2007Approval Inspire Announces FDA Approval Of AzaSite
Aug 28, 2006InSite Vision Announces FDA Acceptance of New Drug Application for Review
Jun 29, 2006InSite Vision Announces Submission of AzaSite NDA
Apr 27, 2006InSite Vision Meets With the FDA on Pre-NDA Discussions

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