Released by FDA: 2/16/01.  Posted by FDA:  2/28/01

Donald F. Baker 
Senior Director, Regulatory Affairs
Fujisawa Healthcare, Inc. 
Parkway North Center, Three Parkway North 
Deerfield. Illinois 60015-2548

Re:    NDA 50-777 
         Protopic (tacrolimus 0.03% and 0.1%) Ointment 
         MACMIS# 9672

Dear Mr. Baker:

As part of its routine monitoring and surveillance program. the Division of’ Drug Marketing, Advertising, and Communications (DDMAC) has become aware of a journal advertisement (ad), disseminated by Fujisawa Healthcare. Inc. (Fujisawa) for Protopic that is in violation of the Federal Food, Drug and Cosmetic Act and applicable regulations.  Specifically, DDMAC refers to the journal ad for Protopic that appears in the December 2000, issue of Prevention Magazine.  The ad states, “Breakthrough research has finally uncovered a new kind of medicine for eczema.  Made of a natural substance, this new treatment is steroid free.”  This ad represents that Fujisawa developed a new kind of medicine for eczema that is made from a natural substance and is steroid free.  Fujisawa makes the only new kind of medicine for eczema that has these characteristics.  Thus, the advertisement identities the specific product without including the information that is required for an advertisement that makes claims about a product.

In order to address these objections, DDMAC recommends that Fujisawa take the following actions:

1. Immediately discontinue the use of this, and all other promotional materials for  Protopic that contain the same or similar violations.
   
   
2. Provide to DDMAC. in writing, your intent to comply with #1 above.  Your response should be received by March 2, 2001.
   
   
3. This response should include a list of all violative promotional materials and Fujisawa's method for discontinuing their use.

If you have any questions or comments, please contact me by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing,  Advertising and Communications, HFD-42, Rm 17B-20, 5600 Fishers Lane, Rockville, MD 20857.   We remind you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #9672 in addition to the NDA number.

Sincerely.

Cheryl Y. Roberts, MS, JD
Regulatory Review Officer 
Division of Drug Marketing, 
     Advertising and Communications