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Nelfinavir (marketed as Viracept) Impurity and Potential Shortage Information
Viracept was recently recalled from the European market due to unacceptably high levels of an impurity known as ethyl methanesulfonate (EMS). EMS is an impurity created during the Viracept manufacturing process. The manufacturing and distributing company for Europe is Roche, whereas Pfizer manufactures and markets Viracept in the United States.
As a consequence of the recall in Europe, Pfizer tested its drug supply of Viracept. Most of the testing has shown EMS levels within final acceptable limits. The FDA and Pfizer have agreed to temporary limits of exposure of this impurity to allow for continued use in populations where the benefits of taking Viracept outweigh potential risks. The manufacturing process is being refined to ensure that EMS levels meet final acceptable limits.
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Date created: September 10, 2007
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