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McNeil Nicotrol Inhaler

This article was originally published in The Tan Sheet

Executive Summary

Revised direct-to-consumer TV ad "fails to sufficiently reveal material facts with respect to consequences that may result from the use of the drug in light of the representations made concerning the use of the Nicotrol Inhaler as recommended or suggested in the advertisement," FDA asserts in an April 6 letter to the firm. The letter addresses TV and print ads and information on the product's Web site (www.nicotrol.com) revised in response to earlier objections relayed by the agency in a March 19 letter ("The Tan Sheet" April 6, In Brief). FDA complains of the ad's "inadequate" communication of the "limitations to the use of the drug," adding the commercial should more clearly advise consumers to seek product information from their doctor or pharmacist. FDA has no objections to McNeil's revisions of the DTC print ad and Web site representations...
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