Caraco Pharmaceutical Laboratories Ltd., announced that the US Food and Drug Administration (FDA) has granted tentative approval for the company's abbreviated new drug application (ANDA) for cetirizine hydrochloride chewable tablets, 5 mg and 10 mg (cetirizine HCl chewable). Final approval to market this product is anticipated subsequent to the expiry of patent protection on December 25, 2007.

Cetirizine HCl Chewable is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens in adults and children 2 years of age and older; perennial allergic rhinitis in adults and children 6 months of age and older; and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. This tentative approval is the bioequivalent to Zyrtec Chewable, a registered trademark of Pfizer, Inc. Zyrtec Chewable tablets had US sales of approximately $75 million for the 12-month period ended June 30, 2007, according to IMS Data.

Daniel H Movens, Caraco's chief executive officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent on December 25, 2007, which will allow Caraco to market the product. We feel that cetirizine HCl chewable complements our previously announced FDA tentative approval of cetirizine hydrochloride immediate release tablets, 5 mg and 10 mg, and both products will be positive additions to our portfolio by expanding our product offerings."