Abbott Zyflo "homemade" step-down dosing promotional materials cited by FDA in June 27 letter.
Executive Summary
ABBOTT ZYFLO "HOMEMADE" STEP-DOWN DOSING PROMOTIONAL MATERIALS CITED by FDA in a June 27 letter to the company. The Division of Drug Marketing, Advertising, & Communications "has received information about various promotional claims, including unapproved Zyflo [zileuton] dosage regimens (i.e., step-down dosing) and unsubstantiated efficacy claims, allegedly being disseminated by Abbott sales representatives in widely varied geographic areas of the U.S.," FDA told the company.