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McNeil

This article was originally published in The Tan Sheet

Executive Summary

Waxman/Hatch marketing exclusivity for chewable forms of Children's Motrin (50 mg ibuprofen) and Junior Strength Motrin (100 mg) expires Nov. 15, 1999, three years after the products' approval date ("The Tan Sheet" Dec. 16, 1996, In Brief). The expiration date previously had been set at June 16, 1998, the expiration date for Children's Motrin oral suspension (100 mg/5 mL). FDA required McNeil to do an additional clinical study on the chewable form that delayed its approval...
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