Advil Migraine Liqui-Gels
This article was originally published in The Tan Sheet
Executive Summary
Whitehall-Robins receives FDA approval for the indication-specific OTC analgesic March 16. Approved under NDA 20-402/S-005, the product is the third nonprescription migraine pain reliever to be cleared by the agency, putting it in a race to market with McNeil Consumer Healthcare's Motrin Migraine Pain, approved Feb. 25 (1"The Tan Sheet" March 6, p. 3). FDA authorized a migraine pain indication for Bristol-Myers Squibb's Excedrin Migraine in January 1998. Advil Migraine Liqui-Gels will contain 200 mg solubolized ibuprofen in liquid-filled capsules and will come in 20-, 40- and 80-count sizes. Labeling will carry the claim "Treats migraine," which Whitehall says applies to migraine symptoms such as nausea and sensitivity to light and sound. The company believes Motrin's approved claim - "Treats pain of migraine headache" - to be more restrictive
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