Released by FDA: 6/25/01.  Posted by FDA:  7/26/01

Daisy Chhatwal, Pharm D.      SC3-735A 
Senior Regulatory Analyst 
US Drug Regulatory Affairs & Compliance 
Aventis Pharmaceuticals 
300 Somerset Corporate Boulevard 
Bridgewater, NJ 08807-2854

RE:   NDA #20-164 
          Lovenox (enoxaparin sodium) Injection 
          MACMIS # 10148

Dear Dr. Chhatwal:

This letter concerns Aventis Pharmaceuticals’ (Aventis) dissemination of promotional materials for Lovenox.  As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed promotional materials for Lovenox submitted by Aventis wider cover of Forms FDA 2253 dated June 6 and June 8, 2001.   The materials included a convention panel (item number 21092601/01171E1) and a sales aid (item number 50058941/21077901/01l472El).    These materials promote Lovenox in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regu1ations. Specifically, we have the following objections:

The convention panel and sales aid lack fair balance because they provide information relating to the effectiveness of Lovenox but fail to provide any information regarding side effects and contraindications (including warnings and precautions).   For example, each provides the seven indications of Lovenox, but fails to include important risk information such as the boxed warning regarding spinal/epidural hematomas.

Neither the established name nor the dosage form appears in the header of the sales aid.   Both are required to appear prominently.

You should immediately slop using these and all other promotional materials with the same or similar presentations.   You should respond to this letter on or before July 10, 200L   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 me by facsimile at (301)594-6771, or at the Food and Drug Administration Division of Drug Marketing Advertising, and Communications HFD-42, Rim 178-20, 5600 Fishers Lane. Rockville, MD 20857.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #10148 in addition to the NDA number.    DDMAC reminds you that only written communications are considered official.

Sincerely,

Margaret M. Kober, R.Ph. 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising, and Communications