AzaSite FDA Approval History
FDA Approved: Yes (First approved April 27, 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 Timeline for AzaSite
|Apr 29, 2007||ApprovalInspire Announces FDA Approval Of AzaSite|
|Aug 28, 2006||InSite Vision Announces FDA Acceptance of New Drug Application for Review|
|Jun 29, 2006||InSite Vision Announces Submission of AzaSite NDA|
|Apr 27, 2006||InSite Vision Meets With the FDA on Pre-NDA Discussions|
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