Viramune ad draws FDA citation
Executive Summary
Boehringer Ingelheim will work with FDA before an Oct. 6 deadline to make appropriate revisions to a Viramune print ad campaign following receipt of a 1letter from agency's drug ad division. Letter references an ad showing a runner standing on a track and includes the tag lines "I am taking on tomorrow"; "The power to suppress viral load"; and "Generally well-tolerated." Below the claims appears a box with "Important Safety Information for Viramune" but that box omits important risk information and is difficult to read, FDA said. A "black box" warning in the HIV therapy's labeling was recently modified (2"The Pink Sheet" Feb. 2, 2004, In Brief). [Editor's note: Coverage of the FDA ad division's warning letter to BI regarding Atrovent and Combivent appears in 3"The Pink Sheet" DAILY]...
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