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FDA approves new chewable formulation of Zyrtec® aimed at young allergy sufferers

Published on March 22, 2004 at 3:37 AM · No Comments

Grape-Flavored Chewable Tablets Offer Efficacy and Convenience for Young Allergy Sufferers

Pfizer Inc and UCB Pharma today announced the approval of a new chewable formulation of Zyrtec® (cetirizine HCl) for the treatment of seasonal and perennial allergic rhinitis (inflammation of the nasal passages) and chronic idiopathic urticaria (itching and hives of unknown causes) in children aged two years and older. The approval by the US Food and Drug Administration makes Zyrtec the first and only prescription antihistamine available in both syrup and chewable form.

"This new chewable formulation provides more convenience and flexibility for a trusted antihistamine,” said Gail Shapiro, MD, Senior Partner, Allergist, Northwest Asthma and Allergy Center, Clinical Professor of Pediatrics, University of Washington School of Medicine and past President of the American Academy of Allergy, Asthma and Immunology. “The chewable option will appeal to physicians, parents, and patients. It offers physicians another option to better meet our patient’s individual needs; for parents it offers easy administration; for patients it offers Zyrtec’s 24-hour symptom relief in a pleasant tasting, easy-to-chew tablet.”

The grape-flavored tablets are formulated to be taken once daily with or without food or water. They will be available in 5 mg and 10 mg doses to allow physicians the flexibility of prescribing the proper dose for children of different ages.

Zyrtec is the number-one prescribed antihistamine by pediatricians and allergists.1 The new chewable formulation, which can be used by children as young as two years old, provides physicians with another Zyrtec option for their pediatric patients. Zyrtec syrup is available for babies as young as six months with year-round allergies or continuing hives. Zyrtec Chewable Tablets are bioequivalent to Zyrtec tablets and offer the same efficacy as Zyrtec tablets and syrup in a convenient formulation. The new chewable tablets will be available in a 30-tablet blister pack containing three cards of 10. Individual, foil-wrapped tablets can be easily removed by separating or bending the packaging perforation. As with all medications, Zyrtec Chewable Tablets should be kept out of the reach of children.

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