FDA approves more children’s Zyrtec equivalents
This article was originally published in The Tan Sheet
Executive Summary
Taro Pharmaceuticals Industries receives FDA approval for its children's cetirizine hydrochloride oral solution 1 mg/mL preparation, the Hawthorne, N.Y.-based firm announces April 22. The product is equivalent to McNeil Consumer Healthcare's Children's Zyrtec Oral Solution. Citing industry sources, Taro says the allergy treatment generated annual U.S. sales of $160 million when it was available only by prescription. Indian drug firm Ranbaxy and Canadian generics manufacturer Apotex also recently received approval for private-label children's cetirizine. Allegan, Mich.-based private labeler Perrigo received approval for its children's Zyrtec equivalent April 9 and also markets generic versions of both adult-indicated Zyrtec products, original Zyrtec (cetirizine 5 mg) and Zyrtec-D extended-release tablets (cetirizine 5 mg/pseudoephedrine 120 mg) (1"The Tan Sheet" April 14, 2008, In Brief)...