AzaSite
Generic name: azithromycin
Treatment for: Conjunctivitis, Bacterial
InSite Vision Meets With the FDA on Pre-NDA Discussions
ALAMEDA, Calif., April 27, 2006 - InSite Vision Incorporated -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced that it had a pre-NDA meeting with representatives of the U.S. Food and Drug Administration (FDA) on Wednesday, April 26, 2006. The purpose of the meeting was to discuss the proposed new drug application (NDA) submission for AzaSite, the Company's ocular anti-infective product. InSite recently announced the successful completion of the second of two required Phase 3 clinical trials to evaluate the safety and efficacy of AzaSite. In this study, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy end point, and a significantly higher bacterial eradication rate, a secondary end point, than those receiving a placebo. The study showed that AzaSite was safe and well tolerated.
"Our pre-NDA meeting with the FDA, in combination with the recent AzaSite Phase 3 clinical trial results, gives us further confidence towards the assembly of our NDA for our lead product AzaSite," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer. "Our discussions with the FDA during this meeting were productive, and will facilitate our full NDA submission which we anticipate could come as early as this quarter."
InSite Vision was pleased to accept the FDA's offer to participate in the implementation of a new program to provide electronic product labeling. Pending the successful filing of the full NDA and approval from the FDA, the Company expects to commercially launch AzaSite in the U.S. in early 2007.
Source: InSite Vision Incorporated
Posted: April 2006
Related articles
- Inspire Announces FDA Approval Of AzaSite - April 29, 2007
- InSite Vision Announces FDA Acceptance of New Drug Application for Review - August 28, 2006
- InSite Vision Announces Submission of AzaSite NDA - June 29, 2006
AzaSite (azithromycin) FDA Approval History
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