Released by FDA: 6/27/00.  Posted by FDA:  7/24/00

Aniia Wysowskyj 
Senior Manager, Regulatory Affairs 
Bausch & Lomb Pharmaceuticals, Inc. 
8500 Hidden River Parkway 
Tampa, FL 33637

RE:    NDA 20-803 
         Alrex (loteprednol etabonate ophthalmic suspension, 0.2%) 
         MACMIS ID # 8889

Dear Ms. Wysowskyj:

This letter refers to Bausch & Lomb Pharmaceuticals, Inc.’s (B&L) submission, dated March 3, 2000, of promotional materials under cover of Form FDA 2253 for Airex. The submission included a professional sales aid (PH1498), and a 4” x 6” magnet (PH1522) titled, “All the signs, all the symptoms.”  The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed the promotional materials and has concluded that they are false or misleading under the Federal Food, Drug, and Cosmetic Act and its implementing regulations.  Our specific objections follow:

Misleading Claims of Superior Efficacy

In the promotional materials, you present a table titled, “Only Airex scores against all the signs and symptoms of seasonal allergic conjunctivitis.”  The table includes the drugs Airex,  Acular, Alocril, Patanol, and Zaditor, and shows 10 symptoms of seasonal allergic conjunctivitis.  Only Airex is depicted to be effective for all the symptoms.  The other products are depicted only to be effective for 1 symptom--itching.  The table is misleading because you claim Alrex is superior to the other products based on labeled indications, but only Airex and Acular have the same indications for use.  Further, your comparison to Acular lacks adequate evidence in the form of adequate and well controlled head-to-head clinical trials.

The other products are indicated for vernal conjunctivitis, vernal keratoconjunctivitis, vernal keratitis, and allergic conjunctivitis.  Thus, comparing Airex to other drugs with different indications is misleading because the other drugs were developed for different uses in different patient populations.  For example, drugs to treat vernal conjunctivitis would alleviate itching, conjunctival hyperemia, mucoid discharge, and papillary hypertrophy.

Requested Actions

In order to address these objections, we request that you immediately cease the dissemination of these violative promotional materials and all similar promotional materials that contain the same or similar messages.

You should respond in writing to us regarding this issue by July 12, 2000. Your response should include B&L’s intent to comply with the above request, the date that it ceased disseminating these and any other violative promotional materials with the same or similar messages, and a list of the discontinued materials.

If you have any questions, please contact me by facsimile at (301) 594-6771, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane; Rockville, MD 20857. We remind you that only written communications are considered official.

In all future correspondence regarding this matter, please refer to MACMIS # 8889 and NDA 20-803.

Sincerely,

 

Warren F. Rumble 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising and Communications