FDAnews
www.fdanews.com/articles/88037-insite-vision-submits-nda-for-azasite-in-the-treatment-of-bacterial-conjunctivitis-with-u-s-fda

INSITE VISION SUBMITS NDA FOR AZASITE IN THE TREATMENT OF BACTERIAL CONJUNCTIVITIS WITH U.S. FDA

June 30, 2006

Thursday, InSite Vision, Inc., an ophthalmic products company, revealed the submission of a New Drug Application or NDA with the U.S. Food and Drug Administration for AzaSite indicated in the treatment of bacterial conjunctivitis. The submission includes positive results from the completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing, and controls.
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