Zyrtec-D Switch Approved – J&J Will Launch Behind The Counter This Year
This article was originally published in The Tan Sheet
Executive Summary
FDA approved Johnson & Johnson's bid to switch prescription antihistamine/nasal decongestant Zyrtec-D to nonprescription status, but the firm is still awaiting a reply on single-ingredient Zyrtec
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FDA approved Johnson & Johnson's bid to switch prescription antihistamine/nasal decongestant Zyrtec-D to nonprescription status, but the firm is still awaiting a reply on single-ingredient Zyrtec . The agency approved J&J's switch application for Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) Nov. 9 for nonprescription use in adults and children 12 years of age and older. Under the Combat Meth Act, the nonprescription version of Zyrtec-D must be sold behind the counter because it contains pseudoephedrine. A second-generation antihistamine, Zyrtec has been available by prescription since 2001. Zyrtec-D will compete with Schering-Plough's Claritin-D and other branded and generic loratadine products. Claritin-D advertising has positioned the product as more efficacious than competitors that were reformulated in order to remain in front of the counter. The nonprescription version of Zyrtec-D is indicated for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion, FDA said. J&J acquired the OTC licensing rights to Zyrtec products through its 2006 purchase of Pfizer Consumer Healthcare (1 (Also see "Zyrtec OTC, New Segments Picked Up From Pfizer Will Be Key Drivers – J&J" - Pink Sheet, 29 Jan, 2007.), p. 11). Pfizer filed switch applications for both Zyrtec and Zyrtec-D, according to J&J's Fort Washington, Pa.-based McNeil Consumer Healthcare subsidiary, which markets Zyrtec products. J&J executives in January said they anticipated launching Zyrtec over the counter late in the year pending FDA's switch approval. The agency did not submit the drug to an advisory panel review. FDA told "The Tan Sheet" the Zyrtec-D switch application "was approved based upon its merits," not due to a citizen petition submitted in March 2007 asking the agency to force switch Sanofi-Aventis's Allegra and Zyrtec to nonprescription (2 (Also see "Antihistamine Forced Switch Proposal Returns In Citizen Petition" - Pink Sheet, 26 Mar, 2007.), p. 3). - Malcolm Spicer ([email protected]) |