Released by FDA: 6/29/01.  Posted by FDA:  7/26/01

Martina Ziska, M.D., Ph.D. 
Deputy Director, Regulatory Affairs 
Bayer Corporation Pharmaceutical Division 
400 Morgan Lane 
West Haven, CT 06516

RE:   NDA#21-085
         Avelox (moxifloxacin HCL) 
         MACMIS ID # 10160

Dear Dr. Ziska:

This letter concerns violative promotional activities by the Bayer Corporation Pharmaceutical Division (Bayer).   As a part of the Division of Drug Marketing, Advertising, and Communications’ (DDMAC) routine surveillance, we have identified statements made by a Bayer sales representative about Avelox (moxifloxadn HCL) in the commercial exhibit hail of the American Society of Health-System Pharmacists’ (ASHP) annual meeting in June, 2001 that are in violation of the Federal Food, Drug, and Cosmetic Act and its applicable regulations.   Specifically, we object to the following:

Promotion of Unapproved Use

Bayer engaged in promotional activities that state or suggest that Avelox is safe or effective for the treatment of penicillin-resistant Streptococcus pneumoniae (PRSP) infections.   At the ASHP annual meeting, a Bayer sales representative stated, “Avelox can be used to treat penicillin-resistant Streptococcus pneumoniae infections,” while promoting the antibiotic coverage of Avelox to visitors at the commercial exhibit booth. This statement promotes Avelox for an unapproved use.

Avelox is indicated for the treatment of adults (a18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

• Acute Bacterial Sinusitis caused by Streptococcus pneurnoniae, Haemophilus influenza, or Moraxella catarrhalis.
• Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenza, Haemophilus parainfluenza, Kiebsiella pneumoniae, Staphylococcus aureus, or Moratella catarrhalis. 
• Community Acquired Pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae, Haemophilus influenza, Mycoplasrna pneumoniae. Chlamydia pneumoniae, or Moraxella catarrhalis.

The approved product labeling (PI) for Avelox clearly states that Moxifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 2 micrograms per milliliter or less against most (> 90%) strains of Streptococcus pneurnoniae (penicillin-resistant strains); however, the safety and effectiveness of moxifloxacin in treating clinical infections due to this microorganism has not been established in adequate and well-controlled clinical trials.   Therefore, promotion of Avelox for the treatment of PRSP infections is violative and is evidence of Bayer’s intent to promote Avelox for unapproved uses.

Requested Action

We request that Bayer representatives immediately cease making such false or misleading statements.  We request that you submit a written response by July 12, 2001 describing your intent and plans to comply with the above.  Your response should include your method of ceasing such oral statements.

You should direct your response to the undersigned by facsimile at (301) 594-6771, or in writing to the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD- 42, Rm 17-B-20, 5600 Fishers Lane, Rockville, MD 20857.   We remind you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID # 10160 in addition to the NDA number.

Sincerely,

James R. Rogers, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
      Advertising, and Communications