FDA nod to Cypress’ Cetirizine HCl Oral Solution

Jim Marino — Thu, 06 Nov 2008 10:35:27 +0000

The U.S. Food and Drug Administration has granted approval to Cypress Pharmaceutical, Inc.’s abbreviated new drug application for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL. This product is an AA-rated generic equivalent to the Zyrtec® Oral Solution developed by McNeil Consumer Healthcare. While Cetirizine HCl Oral Solution’s over-the-counter version is an antihistamine that relieve from indoor and outdoor allergies such as sneezing, runny nose, watery eyes and itchy throat; the prescription version treats symptoms of allergic rhinitis in children who are 6 to 23 months of age and relieve children up to 5 years of age from chronic urticaria (hives).

Immunology Product Guide » Cetirizine HCl Oral Solution

FDA nod to Cypress’ Cetirizine HCl Oral Solution