Released by FDA: 8/18/00.  Posted by FDA:  9/7/00

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

RE:   NDA# 19-658 
        Claritin (loratadine) Tablets 
        NDA# 20-704 
        Claritin (loratadine rapidly-disintegrating tablets) RediTabs 
        NDA# 20-641 
        Claritin (loratadine) Syrup 
        NDA# 20-470 
        Claritin -- D 24 Hour (10 mg loratadine/240 mg pseudoephedrine sulfate) 
                    Extended Release Tablets 
        MACM1S ID#: 9224

Dear Ms. Nehring:

This letter concerns Schering Corporation’s (Schering) dissemination of two direct-to-consumer (DTC) print advertisements for Claritin (loratadine) Tablets. Claritin (loratadine rapidly disintegrating tablets) RediTabs.  Claritin (loratadine) Syrup, and Claritin-D 24 Hour (10 mg loratadine/240 mg pseudoephedrine sulfate) Extended Release Tablets (i.e., magazine wrap CRM 1228).  The Division of Drug Marketing. Advertising, and Communications (DDMAC) has reviewed these ads and concluded that they are misleading and violate the Federal Food, Drug, and Cosmetic Act and applicable regulations and should be discontinued immediately.  Specifically, we refer to the magazine ads appearing as part of the front and back wrap covers of a recent issue of health periodicals.

The full-product Claritin ad appears as a back-to-back combination reminder/help-seeking ad.  On the front of the magazine wrap is a Claritin reminder ad (“Joan Lunden Asks: Curious About Claritin? Ask your doctor’s advice today.”).  This reminder ad is immediately followed by a help-seeking ad on the inside front of the magazine wrap (“Joan Clears the Air About Seasonal Allergies -- 4th in a Series: Reading. Writing, and Ragweed”).  These back-to-back reminder/help-seeking ads convert the entire presentation into one full-product ad for Claritin that includes the product indication and several claims about the effect of allergies on school attendance and children’s attention spans.  This full-product ad is misleading because it fails to provide any risk information relating to side effects and contraindications (including warnings and precautions) to balance the effectiveness claims.  In addition, this ad contains unsubstantiated implied claims that Claritin will impact school attendance and children’s attention spans.  Furthermore, the ad does not include an accompanying brief summary of risk information as required by the advertising regulations.

Similarly, the other full-product Claritin ad appears as a back-to-back combination help-seeking/reminder ad.  On the inside back of the magazine wrap is a help-seeking ad (“Joan Clears the Air About Seasonal Allergies -- 5th in a Series:  Controlling Congestion”).  This help-seeking ad is immediately followed by a Claritin product line reminder ad (“Find Out If Our Family is Right For Yours.. .Talk to your doctor about the Claritin family of medications”) on the back cover of the magazine wrap.  Again, these back-to-back help-seeking/reminder ads convert the entire presentation into one full-product ad for Claritin-D 24 Hour that includes the product indication but omits fair balance and the required accompanying brief summary of risk information.

Schering should immediately cease disseminating and using promotional materials for Claritin and Claritin-D 24 Hour that contain the same or similar claims or presentations. We should receive your written response no later than September 1, 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 arc considered official.

In all future correspondence regarding this matter. please refer to MA(’\11S ID# 9224 in addition to the NDA number.

Sincerely,

Joan Hankin, JD 
Consumer Promotion Analyst 
Division of Drug Marketing. 
   Advertising, and Communications