Released by FDA: 4/10/00.  Posted by FDA:  4/25/00

Kathleen Meriwether 
Senior Director 
Regulatory Services 
Bristol-Myers Squibb Company 
777 Scudders Mill Road 
Plainsboro, NJ 08536

RE:   NDA 21-0611062 
         Tequin (gatifloxacin) Tablets/Injection 
         MACMIS ID#8782

Dear Ms. Meriwether:

It has come to the attention of the Division of Drug Marketing, Advertising, and Communications (DDMAC) that Bristol-Myers Squibb Company (BMS) is promoting its product, Tequin, in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.  Specifically, we refer to your current website¹ for Tequin.  We request that you cease distribution and use of false and/or misleading messages in all promotional materials as outlined below.

Misleading Efficacy Claims

BMS’s website provides misleading efficacy rates for Tequin. BMS states that “Tequin delivers strong clinical efficacy” and utilizes efficacy rates of “> 90% in acute bacterial exacerbation of chronic bronchitis (ABECB), 96% in acute sinusitis (sinusitis), and >97% in community-acquired pneumonia (CAP).”  However, clinical studies used as the basis of approval for Tequin demonstrated efficacy rates of 78-88% for ABECB, 62- 88% for sinusitis, and 73-90% for CAP.  Therefore, BMS is overstating the efficacy rates by selectively presenting higher efficacy rates for Tequin’s use in ABECB, sinusitis, and LAP.

BMS’s website also misleadingly suggests that Tequin is effective against resistant pathogens with the following statement:

For bacteria to develop resistance against Tequin, they must develop mutations in both enzymes.  Thus, the chance of susceptible bacteria to develop resistance to Tequin is extremely low.

BMS’s wording is inconsistent with the approved product labeling (APL),  which states that cross-resistance has been observed between gatifloxacin and some other fluoroquinolones.  Therefore, this presentation is misleading because BMS is selectively presenting information to suggest that Tequin is more effective against resistant - pathogens than has been determined.

Lack of Fair Balance

BMS describes Tequin as being “safe and easy” for patients to take and as having an “excellent tolerability profile.”  Although BMS has disclosed the fact that Tequin has the potential to prolong the QTc interval of the electrocardiogram in certain patients, this serious safety risk is not prominently displayed within the text compared to the above safety claims.  In the APL, this risk information is communicated as a bolded warning.  BMS’s presentation of risk information lacks prominence compared to the benefit claims and minimizes the potential serious risks associated with Tequin therapy.

BMS should immediately cease dissemination of these and similar claims and presentations in all promotional materials for Tequin.  BMS should submit in writing, on or before April 24, 2000, a description of the steps that will be taken to comply with the above request.

BMS should direct its response to the undersigned 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 ID# 8782 and NDA 21-061/062.

Sincerely,

Jean-Ah Choi, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising, and Communications

¹ http://www.tequin.com (current as of April 7, 2000)