Caraco gets tentative FDA OK for generic allergic-rhinitis drug
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)









