Released by FDA: 3/10/00.  Posted by FDA:  3/16/00

C. Elaine Jones, Ph.D.
Product Director, 
Regulatory Affairs 
Glaxo Wellcome Inc. 
5 Moore Drive 
P.O. Box 13398 
Research Triangle Park, NC 27709

RE:    NDA#20-121 
         Flonase (fluticasone propionate) Nasal Spray 
         MACMIS ID# 8784

Dear Dr. Jones:

This letter addresses Glaxo Wellcome Inc.’s (GW) dissemination of a television (TV) broadcast advertisements for Flonase (fluticasone propionate) Nasal Spray (45 second/FLN2O55RO and 60 second/FLN2O56RO).  The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed these TV advertisements as part of its monitoring and surveillance program and concludes that they violate the Federal Food, Drug, and Cosmetic Act and applicable regulations.

The TV advertisements claim Flonase relieves the specific nasal allergy symptom of post-nasal drip (PND).  However, GW has not provided substantial evidence demonstrating that Flonase is effective in treating this particular nasal allergy symptom. Therefore, because these PND efficacy claims are unsubstantiated, they are false or misleading.

GW should immediately cease using these TV advertisements and all other promotional materials for Flonase that contain the same or similar claims or presentations.  We should receive your written response no later than March 24,2000.  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. We remind GW that only written communications are considered official.  In all future correspondence regarding this particular matter, please refer to MACMIS ID# 8784 in addition to the NDA number.

Sincerely,

Joan Hankin, JD 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising, and Communications