India's Ranbaxy gets final US FDA approval for cetirizine hydrochloride tablets
MUMBAI, Dec. 31, 2007 (Thomson Financial delivered by Newstex) -- India's Ranbaxy Laboratories Ltd said it received final approval from the US Food and Drug Administration (US FDA) to manufacture and market allergic drug cetirizine hydrochloride tablets in the US.
The company said the approval is for over the counter sales of the tablets in strengths of 5 mg and 10 mg.
In a filing with the Bombay (OOTC:BBAO) Stock Exchange, Ranbaxy said cetirizine tablets are the generic version of Pfizer Inc's (NYSE:PFE) Zyrtec and used for temporary relief from runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
The total annual market sales for cetirizine hydrochloride tablets as a prescription only product were 1.3 bln usd for the 12 months to end-September, the company said.
Copyright Thomson Financial News Limited 2007. All rights reserved.
The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
December 31, 2007