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.

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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