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Caffeine

This article was originally published in The Tan Sheet

Executive Summary

BMS requests feedback meeting with FDA to discuss three new efficacy studies supporting Category I status for caffeine 130 mg as analgesic adjuvant when combined with acetaminophen. In 1995, agency classified stimulant as Category I for use as analgesic adjuvant in combination with aspirin and acetaminophen or with aspirin alone. However, FDA concluded there were "inadequate clinical data" to support Category I status for caffeine/acetaminophen combo. BMS markets Aspirin-Free Excedrin, which contains the two ingredients. Firms hopes to meet with agency after June 4. FDA has yet to respond
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