Released by FDA: 6/29/00.  Posted by FDA:  7/17/00

Richard K. Bourne, Ph.D. 
Vice President, Regulatory Affairs 
Block Drug Company, Inc. 
257 Cornelison Avenue 
Jersey City, NJ 07302-3198

RE:   NDA50-751 
        Atridox (doxycycline hyclate, 10%) 
        MACMIS ID # 9083

Dear Dr. Bourne:

This Letter refers to Block Drug Company, Inc.’s (Block) submission, dated April 17, 2000, of promotional materials under cover of Form FDA 2253 for Atridox.  The submission included a professional sales aid titled, “There is a simple, fast, and effective treatment for every patient you see with 5 and 6mm pockets” identified as ATX 1542. The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed the sales aid and has concluded that it is false or misleading under the Federal Food, Drug, and Cosmetic Act and its implementing regulations.  Our specific objections follow:

Lack of Fair Balance

Your professional brochure, identified as ATX1542, is misleading because it fails to present any risk information about Atridox.  You have made numerous claims regarding safety and efficacy for the product, but have not provided information regarding the warnings, precautions, and adverse reactions associated with the use of the drug.  For example, the approved product labeling for Atridox includes a prominent warning concerning possible permanent discoloration of the teeth in certain patients taking drugs of this type.

Requested Action

In order to address these objections, we request that you immediately cease the dissemination of this violative sales aid and all similar promotional materials that lack fair balance.  

You should respond in writing to us regarding this issue by July 13, 2000. Your response should include Block’s intent to comply with the above request, the date that it ceased disseminating the sales aid and any other violative promotional materials lacking fair balance, and a list of the discontinued materials.

If you have any questions, please contact me by telephone at (301) 827-2831, facsimile (301) 594-6771, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane; Rockville, MD 20857.  DDMAC reminds Block that only written communications are considered official.

In all future correspondence regarding this matter, please refer to MACMIS # 9083 and NDA 50-751.

Sincerely,

Warren F. Rumble 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising and Communications