Prolacria
Generic name: diquafosol tetrasodium
Treatment for: Dry Eye
Inspire Continues Discussions with FDA on Dry Eye Program
DURHAM, N.C., October 5, 2006 - Inspire Pharmaceuticals, Inc. met with the U.S. Food and Drug Administration (FDA) in late September 2006 to continue ongoing discussions related to Inspire's dry eye clinical program for Prolacria (the proposed U.S. trade name for diquafosol tetrasodium ophthalmic solution 2%).
Based on this meeting, Inspire plans to provide the FDA with additional information to facilitate ongoing discussions related to Prolacria. Inspire expects to meet with the FDA again following the FDA's review of this information.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "We believe our discussions with the FDA have been constructive but the overall program remains challenging and the outcome is uncertain."
Posted: October 2006
Related articles
- Inspire Announces Outcome of FDA Meeting on Dry Eye Program - March 28, 2006
- Inspire Announces Receipt of FDA Approvable Letter for Diquafosol - December 2, 2005
- Inspire Submits Amendment to New Drug Application for Diquafosol for the Treatment of Dry Eye - June 1, 2005
- Inspire Pharmaceuticals Announces Outcome of Meeting with the FDA on Diquafosol - January 30, 2004
Prolacria (diquafosol tetrasodium) FDA Approval History
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