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FDA approves private label ibuprofen PM

This article was originally published in The Tan Sheet

Executive Summary

FDA approves Perrigo's OTC ibuprofen and diphenhydramine citrate tablets, the Allegan, Mich.-based private-labeler says Dec. 29. Perrigo will ship the product in the first quarter of 2009. Estimated sales of the comparable Wyeth Consumer Healthcare product, Advil PM tablets, were $70 million in the 12 months ending Sept. 28 (1"The Tan Sheet" Nov. 3, 2008, In Brief)

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The company says Oct. 29 it expects final clearance to launch a private-label version of Wyeth Consumer Healthcare's Advil PM tablets after Wyeth's exclusivity ends, Dec. 21, 2008. FDA granted tentative approval for Perrigo's abbreviated new drug application for the non-steroidal anti-inflammatory drug (ibuprofen 200 mg and diphenhydramine citrate 38 mg) indicated as a pain reliever and sleep-aid. According to Allegan, Mich.-based Perrigo, Advil PM U.S. sales totaled $70 million in the 12 months ending Sept. 28. Perrigo includes sales of an ibuprofen/diphenhydramine citrate product in the $275 million it expects to generate from more than 25 products launched between February 2007 and June 2009 (1"The Tan Sheet" Aug. 25, 2008, p. 11)

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