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Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R)
Date:12/28/2007

DETROIT, Dec. 28 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets, "over the counter", (OTC), 5 mg and 10 mg, (Cetirizine HCl).

Cetirizine HCl, which will be marketed as two separate OTC products in two strengths of 5 mg and 10 mg, is an antihistamine drug, which is used to treat allergies, hives, and other allergic inflammatory conditions. These new products are the bioequivalent to Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R), registered trademarks of Pfizer, Inc.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to have the opportunity to market these products as they represent the first "over-the counter" products to be added to our current portfolio of prescription products. Zyrtec Allergy(R) has just been approved for the OTC market and we are pleased to be able to market a generic OTC version as an alternative. It previously was marketed strictly as a prescription product under the Zyrtec(R) brand name where it had done over $1.3 billion in prescription sales. We continue to focus on working towards expanding our product offering as quickly and effectively as possible. We plan to market these products to the generic pharmaceutical and OTC market immediately. This will bring our total product selection to 45 different products represented by 96 various strengths."

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drug
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SOURCE Caraco Pharmaceutical Laboratories, Ltd.
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