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Wyeth ibuprofen comments

This article was originally published in The Tan Sheet

Executive Summary

Advil marketer requests 90-day extension to submit comments on ibuprofen inclusion in internal analgesics tentative final monograph. In Oct. 11 letter to FDA, Wyeth notes it delayed completion of its comments "so that consideration could be given to the impact of the NDAC discussions on product labeling." Firm says it will use the extra time to review safety data FDA cited in support of new GI, renal label warning statements if ibuprofen is added to TFM. Wyeth also might conduct consumer research "that could provide information relevant to the crafting of a label which achieves the intended communication goal and further maximizes safe and appropriate use," the letter states. FDA issued the proposed amendment in August (1"The Tan Sheet" Aug. 26, 2002, p. 3)...

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