Perrigo gets FDA OK for children’s cetirizine
This article was originally published in The Tan Sheet
Executive Summary
Allegan, Mich.-based Perrigo receives FDA approval for its children's cetirizine hydrochloride oral solution (allergy) and children's cetirizine hydrochloride oral solution (hives-relief), 1 mg/mL, preparations, according to a letter from the agency April 9. The products are equivalent to McNeil Consumer Healthcare's Children's Zyrtec Oral Solution (Allergy) Children's Zyrtec Oral Solution (Hives-Relief), the agency states. Perrigo filed Abbreviated New Drug Applications for the children's versions of the allergy medication in December, according to the letter. Perrigo already markets a private-label equivalent to the adult-indicated Zyrtec (cetirizine 5 mg) and received approval for a generic version of Zyrtec-D extended-release tablets (cetirizine 5 mg/pseudoephedrine 120 mg) March 6 (1"The Tan Sheet" March 10, 2008, In Brief). FDA approved both Zyrtec products for OTC use in November, and Perrigo was first to launch its Zyrtec equivalent in January, ahead of the branded product ("2The Tan Sheet" Nov. 19, 2007, In Brief and "3The Tan Sheet" Feb. 11, 2008, p. 9)...
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