Released by FDA: 5/26/00.  Posted by FDA:  7/14/00

Ms. Mary Jane Nehring 
Director, Worldwide Regulatory Affairs 
Schering Corporation 
2000 Galloping Hill Road 
Kenilworth, NJ 07033

RE:    NDA# 19-658 
         Claritin (loratadine) Tablets 
          MACMIS ID#: 9004

Dear Ms. Nehring:

This letter concerns Schering Corporation’s (Schering) dissemination of a piece of health professional promotional labeling (i.e., sales aid CRM 1062) for Claritin (loratadine) Tablets.  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this sales aid and concluded that it contains a misleading safety claim.  This promotional material violates the Federal Food, Drug, and Cosmetic Act and applicable regulations and should be discontinued immediately.

The sales aid includes the headline “Safe, Simple Options” with various claims, including “Approved by the FAA for use by pilots.”  The presentation of this safety claim implies that the Federal Aviation Administration (FAA) has unconditionally approved the use of Claritin for airline pilots.

However, this claim is misleading without additional context qualifying the FAA “approval.”  Furthermore, this unqualified promotional presentation could have safety implications.  As you are aware, such a FAA medical certification is granted on an individual basis and only after a pilot meets certain conditions regarding use of the medication.  These conditions include documenting that the pilot used the medication long enough to demonstrate stability and absence of unacceptable side effects that might affect aviation safety.

Schering should immediately cease using promotional materials for Claritin that contain the same or similar claims or presentations.  We should receive your written response no later than June 12, 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 l7-B-20, 5600 Fishers Lane, Rockville, MD 20857. DDMAC reminds Schering that only written communications are considered official.

In all future correspondence, regarding this matter, please refer to MACMIS ID# 9004 in addition to the NDA number.

Sincerely,

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