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Irvine-Based Sicor Beats Back Appeal

May 19, 2000|Bloomberg News

AstraZeneca Plc, Europe's largest drug maker, has lost an appellate court bid to force the U.S. Food and Drug Administration to rescind its decision to allow Sicor Inc. to market a generic form of the Diprivan anesthetic.

London-based AstraZeneca asked the FDA as early as 1998 not to approve generic versions of the drug, which has hypnotic properties and is used in hospital intensive care units. The company said copies of the drug could contain different preservatives and may be unsafe.

The FDA approved Irvine-based Sicor's application in early 1999. AstraZeneca filed a complaint in U.S. District Court in Baltimore, asking a judge to block the approval. The court, in August, rejected AstraZeneca's plea. The 4th U.S. Circuit Court of Appeals in Richmond affirmed that decision Wednesday.

"There is no basis in the record before us to hold that the FDA acted arbitrarily and capriciously in approving [Sicor's application]," the three-judge appeals panel said in a 14-page opinion.

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