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« Regulation to Require the Use of Bear Resistant Canisters | Main | High Gas Prices are Sparking Calls for Regulation » August 24, 2005Drug Maker Seeks Approval of Relenza In Preventing FluAccording to theWall Street Journal GlaxoSmithKline PLC said it is in talks with U.S. and European drug regulators for the approval of antiviral drug Relenza for preventing influenza.The drug, launched in 1999 as the world's first influenza antiviral, is currently approved for the treatment, rather than prevention, of flu. The U.K. company is also seeking regulators' approval of an extension of the drug's shelf life from three to five years, a GlaxoSmithKline spokesman said. GlaxoSmithKline is also investigating different delivery methods for Relenza, which is administered through an inhaler. "We are looking at intravenous methods, which wouldn't be for everyday usage but for people who are hospitalized," the spokesman said. However, he added that an eventual regulatory approval for alternative-delivery methods would be two or three years away." With the possibility of Avian Flu, it might be nice to work on this quicker. Related from the Joint Center: Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process Ernst R. Berndt, Adrian H. B. Gottschalk, Tomas J. Philipson, Matthew W. Strobeck Posted by the Joint Center at August 24, 2005 09:22 AM |
