You are here

Approvable Letter Issued for Diquafosol Tetrasodium

DURHAM, NC - December 22, 2003 - Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for diquafosol tetrasodium ophthalmic solution for the treatment of dry eye.

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.

More Headlines

Liver Fluke Infestation Affects Almost 2.5 Million People Globally
Policy Could Be Life-Changing for People With Spinal Cord Injury
Test Determines Severity of Pain, Helps Physicians Select Best Options
Intratumoral Injection Stimulates Immune Activation
Diabetes and Cancer Patients Could Soon Avoid Injections
Early Cancer Development May Begin in Just 30 Minutes