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Oct 5
Tentative FDA Approval for Generic Zyrtec Chewable

Caraco Pharmaceuticals (AMEX:CPD)  announced today that they have received tentative approval to market their generic version of Zyrtec Chewable, Cetirizine HCl Chewable. They are expecting final approval prior to the expiration of the patent in December of this year.

Seasonal%20Allergies.jpgCetirizine HCl Chewable is used for the relief of nasal symptoms of seasonal allergies and is the bioequivalent of Pfizer Inc's Zyrtec Chewable which has U.S. sales of $75 million from June 2006 to June 2007.

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."

 


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