Released by FDA: 7/24/00.  Posted by FDA:  8/2/00

David Garbe 
Director, Scientific Information and Medical Compliance 
Allergan 
2525 Dupont Drive TL-lL 
P.O. Box 19534 
Irvine, CA 92623-9534

RE:      NDA20-428 
           Azelex (Azelaic Acid) 20% Cream 
           MACMIS# 8735

Dear Mr. Garbe:

As part of our routine monitoring program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of promotional materials for Azelex (Azelaic Acid) 20% cream by Allergan, Inc. that violate the Federal Food, Drug and Cosmetic Act (Act) and its implementing regulations.  Reference is made to selected promotional materials for Azelex, including sales aid SIMCOO-099, journal advertisement SIMCOO-089, and “Dear Doctor” sample letter S1MC99561 submitted under cover of Form FDA 2253.  We have reviewed these materials and have determined that they promote an unapproved new drug, namely the combination of Azelex and 4% Benzoyl Peroxide (Azelex/BPO)¹.

Unapproved New Drug

In your promotional materials, you make several claims and presentations relating to the safety and efficacy of Azelex/BPO as if it were an approved product.  Examples include, “A winning combination,” “Azelex and BPO:  A winning combination vs. Benzamycin²,” and “Play your cards right with Azehex and BPO.”  These claims and representations promote an unapproved new drug, in violation of the Act.

Comparative superiority claim of unapproved drug vs. approved drug

In your promotional materials, you make several superiority claims comparing an unapproved drug (Azelex/BPO), with an approved drug, Benzamycin.  These claims include, but are not limited to:

• Effective: Greater reduction in mean inflammatory lesions at all time points

• Well Tolerated: Less dryness, burning, and scaling at all time points

• Significantly greater decrease in mean overall disease severity score at week 8

• Significantly greater increase in mean overall global improvement score at weeks 8 and 12

• Higher overall patient preference rating

These superiority claims for Azelex/BPO are false or misleading because the safety and efficacy of Azelex/BPO, an unapproved new drug, has not been established. 

Action Requested

You should immediately cease distribution of these promotional materials and all other promotional materials for Azelex that contain the same or similar claims or presentations cited in this letter.  You should submit a written response to us, on or before 10 business days, describing your intent and plans to comply with the above.  In your letter to us, you should include a list of all promotional materials that were discontinued, and the discontinuation dates.

You should direct your response 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 17B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official. In all correspondence regarding this particular submission, please refer to MACMIS ID# 8735 in addition to the NDA number. 

Sincerely,

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

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¹   In certain promotional materials, Brevoxyl® of Stiefel Laboratories, Inc. is referenced as the 4% Benzoyl peroxide used in the Azelex/BPO combination. 

²  Benzamycin® of Dermik Laboratories, Inc. is an approved drug combination product of 3% erythromycin and 5% benzoyl peroxide.