Released by FDA: 11/21/00.  Posted by FDA:  12/6/00

Ms. Barbara Goulding 
Supervisor, Regulatory Affairs 
American Regent Laboratories, Inc. 
One Luitpold Drive 
Shirley, New York 11967

RE:   NDA 21-135 
        Venofer (Iron Sucrose Injection) 
        MACMIS ID # 9526

Dear Ms. Gouiding:

This letter addresses the dissemination by American Regent Laboratories, Inc., (ARL) of a "reminder advertisement for Venofer (iron sucrose injection), identified as TAV-2340A.  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this advertisement as part of its monitoring and surveillance program and has concluded that the advertisement is in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations.

Reminder advertisements call attention to the name of the drug product, hut may not contain written, printed, or graphic matter containing representations or suggestions relating to the drug product.  The reminder advertisement for Venofer injection includes the words, "new" and the foundation for the future.”  Thus, the advertisement makes a representation about the product.

Promotional materials must also be submitted to DDMAC for review at the time of initial dissemination in compliance with 21 CFR Sec 314.81.  Our records indicate that this promotional material has not yet been submitted for review.

DDMAC requests that ARL immediately cease using this advertisement and all other promotional materials for Venofer that contain the same or similar claims or presentations.  You should submit a written response to DDMAC, on or before December 6, 2000, describing its intent and plans to comply with the above.  In its letter to DDMAC, you should include a list of all promotional materials that were discontinued, and the discontinuation date.

ARL should direct its response to Patricia Staub by facsimile at (301) 594-6759, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane; Rockville, MD 20857.

In all future correspondence regarding this matter, please refer to MACMIS #9526 and the NDA number.

Sincerely,

Patricia Kuker Staub, R.Ph, J.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
        Advertising, and Communications