Caffeine dosing change requires reproposal of analgesics TFM, Bristol-Myers asserts.
This article was originally published in The Tan Sheet
Executive Summary
BRISTOL-MYERS ASSERTS FDA MUST REPROPOSE TFM TO SET 65 MG CAFFEINE DOSE in an Aug. 21 submission to FDA in support of caffeine as analgesic adjuvant. FDA told Bristol-Myers Squibb and other analgesics manufacturers in April 18 letters that it is planning to lower caffeine levels to 64 or 65 mg per dose in the upcoming analgesics final monograph ("The Tan Sheet" May 8, p. 4). The 1988 tentative final monograph on internal analgesics set a caffeine limit of 150 mg per dose.