India's Cadila gets tentative FDA nod for anti-epileptic drug Topiramate |
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Wed, 06 Jun 2007 12:34
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MUMBAI (Thomson Financial) - India's Cadila Healthcare Ltd said it has received tentative approval from US Food and Drug Administration for anti-epileptic drug Topiramate.In a statement to Bombay Stock Exchange, Cadila said -- citing estimates by US-based NDC Health, a healthcare information provider -- 2006 branded sales of Topiramate tablets, which is part of the market's central nervous system segment, was about 1.85 bln usd.Cadila said the Topiramate tablets in the strengths of 25 mg, 50 mg, 100 mg and 200 mg are scheduled to be launched in September 2008 upon patent expiry.Separately, in March, it was reported that healthcare giant Johnson & Johnson Inc (J&J) said a US federal judge barred Mylan Laboratories Inc from selling a generic version of the drug Topamax, which contains the active ingredient Topiramate.The permanent injunction keeps Mylan from selling Topiramate tablets and capsules in the US until the patent held by J&J unit Ortho-McNeil Neurologics expires in 2008, J&J said.ami.shah@thomson.comami/aku/ami/amCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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