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Approvable Letter Issued for Diquafosol Tetrasodium
In the letter, the FDA requested that Inspire provide an additional clinical study. Inspire plans to meet with the FDA as soon as possible to determine whether study 03-108, which was completed after the New Drug Application was submitted, will be sufficient to meet this requirement. No other specific deficiencies were noted in the approvable letter. The letter indicated that comments on proposed labeling will be provided by the FDA when the clinical issues have been adequately addressed.
Christy L. Shaffer, Ph.D., Inspire's CEO, stated, "We are committed to working with the FDA to address the Agency's additional requirements for approval of this important product."
Source: Inspire Pharmaceuticals, Inc.