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BMS citizen petition

This article was originally published in The Tan Sheet

Executive Summary

Novartis Consumer Health has assumed ownership of a July 2001 citizen petition filed by Bristol-Meyers Squibb regarding use of 130 mg caffeine as an adjuvant to OTC analgesics, the firm informs FDA during a Jan. 19 teleconference. The petition is "still under review," according to FDA. Novartis has requested that it be allowed to meet with the Office of Nonprescription Products prior to the issuance of a response if the review findings are "not in favor" of the petition, according to minutes of the conference. The petition asks the agency to consider classifying caffeine 130 mg as Category I (safe and effective) when combined with aspirin or acetaminophen (1"The Tan Sheet" Aug. 13, 2001, p. 3). Novartis' purchase of Bristol's consumer unit - including caffeine-containing Excedrin - was announced in July 2005...
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