Released by FDA: 11/9/00.  Posted by FDA:  12/6/00

Rita A. Wittich 
Vice President, Worldwide Regulatory Strategy 
Pfizer Inc. 
235 East 42 Street 
New York, NY 10017

RE:   NDA# 50-710 
        Zithromax (azithromycin for oral suspension) 
        MACMIS ID#:  9490

Dear Ms. Wittich:

This letter addresses Pfizer Inc.'s (Pfizer) dissemination of’ a television broadcast “reminder advertisement for Zithromax (azithromycin for oral suspension) (ZC316A99).   The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed this advertisement and concluded that it 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, but may not contain written, printed, or graphic matter containing representations or suggest ions relating to the drug product.   The focus of graphics in the reminder advertisement emphasizes the use of Zithromaz oral suspension in children, along with the audio statements “Pfizer brings parents the letter “Z" for Zithromax.  More information about Zithromax is just a click away at www.pfizerkids.com" (and accompanying graphic of the website www.pfizerkids.com).  Therefore, the advertisement in total, with the graphics and verbal statements, make a representation about use of Zithromax oral suspension in a specific patient population.

Pfizer should immediately cease using this television advertisement and all other promotional materials for Zithromax oral suspension that contain the same or similar claims or presentations.  We should receive your written response no later than November 27, 2000, and it should list similarly violative materials, with a description of your method of discontinuation, and the discontinuation date.

Your response should be directed to the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm 17-B-20, 5600 Fishers Lane, Rockville, MD 20857.

DDMA reminds Pfizer that only written communications are considered official.  In all future correspondence, regarding this matter, please refer to MACMIS ID# 9490 in addition to the NDA number.

Sincerely,

 

Joan Hankin, JD
Consumer Promotion Analyst
Division of Drug Marketing,
    Advertising, and Cmmunications