Alcon Laboratories, Inc. (ACL) Receives Approvable Letter From FDA For RETAANE Suspension
10/19/2005 5:09:50 PM
FORT WORTH, Texas--(BUSINESS WIRE)--May 24, 2005--Alcon, Inc. (NYSE:ACL) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its New Drug Application (NDA) for RETAANE(R) 15 mg (anecortave acetate suspension). RETAANE(R) suspension is an investigational treatment for preserving the vision of patients with wet age-related macular degeneration (AMD).
Alcon said it will meet with the FDA to discuss the approvable letter, the clinical studies submitted with the NDA and other ongoing clinical studies for RETAANE(R) suspension to determine the steps necessary to gain final approval for the wet AMD indication.