Roche says expects to re-launch aids drug Viracept marketing in Sept/Oct |
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Tue, 07 Aug 2007 13:40
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ZURICH (Thomson Financial) - Roche Holding AG said it expects to recommence the marketing of aids drug Viracept in September or October, depending on approval by EU authorities.Earlier today, the EU Commission announced it had suspended marketing authorisation for the drug following the European Medicines Agency's suspension of Viracept in June, which followed the recall of Viracept by the drug's maker Roche.Roche said at the time that it had pulled the drug after certain batches were found to be contaminated with ethyl mesilate, a genotoxic substance.The suspension can only be lifted by a further decision by the commission, after an assessment by the EMEA of new data, the EU Commission said.Roche said that it is cooperating closely with authorities in terms of improving the manufacturing process.andrew.ge.thompson@thomson.comat/gpCOPYRIGHTCopyright 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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EU suspends marketing authorisation for Roche HIV-1 drug Viracept 