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Caraco gets tentative FDA OK for generic allergic-rhinitis drug

Fri Oct 5, 2007 12:28pm EDT

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Oct 5 (Reuters) - Caraco Pharmaceutical Laboratories Ltd (CPD.A) said U.S. health regulators granted a tentative approval for its generic version of Pfizer Inc's (PFE.N) Zyrtec chewable tablets used to treat symptoms associated with allergic rhinitis.

Regulatory News

The approval is for Cetirizine HCl chewable tablets, 5 mg and 10 mg, Caraco said in a statement. The final approval to market the product is expected after the expiry of patent protection on Dec. 25, it said.

Zyrtec Chewable tablets had U.S. sales of about $75 million for the 12-month period ended June 30, according to health information provider IMS Data. (Reporting by Aniruddha Basu in Bangalore)



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