FDA clears Zyrtec line extension
This article was originally published in The Tan Sheet
Executive SummaryMcNeil Consumer Healthcare gains regulatory approval for Zyrtec Allergy orally disintegrating tablets (cetirizine 10 mg). In a Sept. 3 1letter, FDA's Division of Nonprescription Clinical Evaluation green-lights McNeil's new drug application, submitted in November 2009, for 6-, 12-, 24- and 66-count cartons of the OTC. The Johnson & Johnson subsidiary has fulfilled the pediatric study requirements for the Zyrtec extension, FDA adds. J&J/McNeil declined to comment on when the tablets will launch. With generics readily available, Zyrtec and other brands seek innovative delivery formats to stay a step ahead of private label (2"The Tan Sheet" Oct. 6, 2008)
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