Released by FDA: 4/2/01.  Posted by FDA:  5/15/01

Lynn Mellor, Associate Director 
James Rawls, Assistant Director 
Drug Regulatory Affairs 
Novartis Pharmaceuticals Corporation 
59 Route 10 
East Hanover, NJ 07936

RE:   NDA#20-313
         NDA #20-823 
         Miacalcin (calcitonin-salmon) Nasal Spray 
         Exelon (rivastigmine tartrate) capsules 
         MACMIS # 9897

Dear Ms Mellor and Dr. Rawls:

As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of convention panels for Miacalcin and Exelon that appeared in the commercial exhibit hail of the American Pharmaceutical Association meeting in March, 2001.  The convention panels promote Novartis Pharmaceuticals Corporation’s drug products in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Specifically, we have the following objections:

Lack of Fair Balance

The convention panels lack fair balance because they provide information relating to the effectiveness of Miacalcin and Exelon but fail to provide any information regarding side effects and contraindications (including warnings and precautions).  For example, the Exelon panel provides the indication (i.e., “for mild to moderate Alzheimer’s Disease”), but fails to include important risk information such as the recently revised bolded warning regarding severe vomiting and esophageal rupture.  Similarly, the Miacalcin panel provides the indication without any important risk information.

Failure to Submit

Promotional materials must be submitted to DDMAC under cover of Form FDA 2253 at the time of initial use.  Our records indicate, however, that you have not yet submitted the Exelon convention panel.

Conclusion and Recommendation

You should immediately stop using these violative panels and all other promotional materials with the same or similar presentations. You should respond to this letter on or before April 16, 2001.  Your response should include your intent to comply with this request and a list of all similarly violative materials that will be discontinued as a result of this letter.  It should be directed to either of us 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. DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID# 9897 in addition to the NDA numbers.

Sincerely,

Margaret M. Kober, R.Ph.
Lisa L. Stockbridge, Ph.D. 
Regulatory Review Officers 
Division of Drug Marketing, 
     Advertising, and Communications