Prolacria
diquafosol tetrasodium
Treatment for Dry EyeInspire Announces Outcome of FDA Meeting on Dry Eye Program
Additional Information to be Provided to FDA as Next Step
DURHAM, N.C., March 28, 2006 -- Inspire Pharmaceuticals, Inc. met with the U.S. Food and Drug Administration (FDA) on March 22, 2006 regarding the approvable letter received from the FDA on December 1, 2005 for diquafosol tetrasodium ophthalmic solution. The meeting with the FDA involved a broad discussion of Inspire's dry eye clinical program for diquafosol.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, "Based upon this meeting, we intend to provide the FDA with additional information to facilitate ongoing discussions related to diquafosol. We have discussed these plans with our partner, Allergan, Inc., and appreciate Allergan's support throughout this process. We expect to provide the information to the FDA and continue our discussions with them over the next several months."
Source: Inspire Pharmaceuticals, Inc.
Related Articles:
Inspire Continues Discussions with FDA on Dry Eye Program - October 5, 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
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