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Perrigo

This article was originally published in The Tan Sheet

Executive Summary

Ibuprofen oral suspension 100 mg/5 mL (ANDA 74-937) granted FDA approval. The reference drug is McNeil's Children's Motrin liquid, for which marketing exclusivity expired Dec. 16. In its Dec. 22 letter, FDA notes the first firm to submit an ANDA for the product "has relinquished its eligibility for the 180-day exclusivity" associated with being the first to file. The approval follows FDA clearance of Perrigo's application to market ibuprofen concentrated drops ("The Tan Sheet" Dec. 21, 1998, In Brief). Three-year Waxman/Hatch exclusivity for McNeil's product was set to expire in June; however, submission of pediatric use data held off private label competition an additional six months ("The Tan Sheet" July 6, 1998, In Brief). Perrigo and Alpharma previously received tentative approval letters from the agency for ibuprofen suspension
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