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Bristol-Myers Squibb's Excedrin gains first approval for OTC migraine indication.

This article was originally published in The Tan Sheet

Executive Summary

EXCEDRIN MIGRAINE TO REACH SHELVES BY LATE MARCH: Bristol- Myers Squibb's NDA 20-802 for the new analgesic claim was approved by FDA Jan. 14. The product is the same formulation as the over 20-year-old Excedrin Extra Strength (250 mg aspirin, 250 mg acetaminophen, 65 mg caffeine per dosage unit) and is indicated for "treatment of mild to moderate migraine pain."
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