RetaaneTreatment for Macular Degeneration
Alcon Submits Retaane - Drug Applications to U.S. and European Regulatory Authorities
FORT WORTH, Texas, --December 16, 2004 - Alcon, Inc. (NYSE:ACL) has submitted the third and final reviewable unit of its New Drug Application (NDA) for Retaane 15 mg (anecortave acetate for depot suspension) to the U.S. Food and Drug Administration (FDA). The application is subject to formal acceptance by the FDA, which could take up to 45 days from the date of submission. Alcon also has submitted its European Marketing Authorisation Application (MAA) for Retaane suspension. Alcon is seeking approval of the drug as a treatment for patients with subfoveal choroidal neovascularization due to age-related macular degeneration.
In the U.S., Retaane depot is being reviewed under the FDA's new Pilot 1 Continuous Marketing Application (CMA) program for fast track designated products, which allows designated NDAs to be submitted in specified reviewable units as each is completed, with each one assigned its own six-month review target.
The FDA has completed its initial review of the Retaane depot Chemistry, Manufacturing and Controls unit, which was filed in 2003, and the Pre-Clinical unit, which was filed in March of 2004. Alcon has responded to all questions posed by the FDA to date. The FDA also has completed its pre-approval inspection of Alcon's manufacturing facility, with no negative findings (no 483 observations).
Alcon, Inc. is the world's leading eye care company. Alcon, which has been dedicated to the ophthalmic industry for over 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon has been conducting retinal research for more than 15 years and is the world's leading provider of surgical equipment used by vitreoretinal specialists who treat patients with AMD and other retinal diseases.
Posted: December 2004
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- Alcon Receives Approvable Letter from FDA for Retaane Suspension - May 24, 2005
- Alcon Updates Filing Status of Retaane New Drug Application - June 30, 2004