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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The European Medicines Agency?s Committee for Medicinal Products for Human Use recommended the lifting of the suspension of the marketing authorization for ?Viracept? (nelfinavir mesylate) from Roche and the re-introduction of the drug in the European Union.
London (Sept. 20)-The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended lifting the suspension of the marketing authorization for “Viracept” (nelfinavir mesylate) from Roche (Basel, Switzerland) and suggested the re-introduction of the drug in the European Union.
The marketing authorization for Viracept was suspended on Aug. 6, 2007, following the contamination during the manufacturing process of several batches of the active substance with ethyl mesylate, a known genotoxic substance.
“The CHMP has assessed the corrective and preventive measures put in place by Roche, and these have also been verified by an inspection of the manufacturing site,” said EMEA in a release. “As a result, the CHMP has been reassured that the cause of the contamination has been eliminated and that future production of Viracept would meet the required quality standards.”
The CHMP has recommended that the European Commission lift the marketing authorization suspension. Once this decision has been made, Roche will be able to resume supply of Viracept.
European Medicines Agency Addresses Viracept Recall; Recommends Suspending Marketing Authorization (June 21, 2007)
Roche Recalls Viracept (June 7, 2007)