Glaxo Wellcome Agenerase

Resistance and tolerability claims for amprenavir are cited by FDA's ad division for being "inconsistent" with approved labeling in a June 4 letter. The letter notes that "there are no results from controlled trials evaluating long-term suppression of HIV RNA or disease progression with Agenerase," yet a promotional toll-free number, staffed by a Glaxo representative, makes a claim that Agenerase has a "unique resistance profile, better resistance, and lower resistance," and that Agenerase is "not-cross resistant with other protease inhibitors." Agenerase therapy is also characterized as "well-tolerated," which FDA said is "misleading," despite Glaxo's mention of some of the warnings, adverse events and precautions associated with the drug. The agency added that the promotional message presented during the telephone call "appeared to have been read from previously prepared promotional labeling...[which] was not submitted" to FDA's ad division. Glaxo has ceased the promotional activity cited