US Food and Drug Administration has granted tentative approval for the Caraco's Abbreviated New Drug Application for Cetirizine HCL, 5mg and 10mg Immediate Release tablets.
Final approval to market this product is anticipated subsequent to the expiry of patent protection in December 25, 2007.
Cetirizine HCL is an antihistamine drug, which is used to treat allergies, hives, and other allergic inflammatory conditions. This new product is the bioequivalent to Zyrtec(R), a registered trademark of Pfizer, Inc. Zyrtec(R) tablets had U.S. sales of approximately $1.21 billion for the 12-month period ended December 31, 2006, 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 in December 2007, which will allow Caraco to market the product. We feel that generic Zyrtec(R) will be positive addition to our portfolio by expanding our product offerings."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.