Skip to Content

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

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide