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Perrigo

This article was originally published in The Tan Sheet

Executive Summary

Receives marketing clearance Dec. 16 for ibuprofen oral suspension 40 mg/mL concentrated drops (ANDA 75-217). The product is equivalent to McNeil Consumer Products' Children's Motrin Concentrated Drops, for which patent exclusivity expired Dec. 16. Exclusivity for the NDAed drug originally was set to expire June 16, but McNeil gained an extra six months of exclusivity under a FDAMA provision that allows extra sole marketing time for studies in pediatric populations. Perrigo and Alpharma have a joint licensing agreement to market, sell and distribute children's oral ibuprofen suspension in the U.S

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