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Ibuprofen petition

Executive Summary

FDA formally alerts industry of Boots' petition to forestall ANDAs for 300 mg, 400 mg and 600 mg ibuprofen. Notice in Federal Register on Sept. 27 points out that Boots has petitioned for 2-year exclusivity for those dosages. Boots submitted the petition to FDA on May 15 based on the 1982 approval for the dysmenorrhea indication ("The Pink Sheet" June 10, T&G-3).
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