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U.S. Court Rejects Challenge to Sicor Drug

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Bloomberg News

A federal court rejected a lawsuit seeking to force the Food and Drug Administration to rescind its approval of Sicor Inc.’s generic version of an anesthetic drug made by AstraZeneca Plc, Irvine-based Sicor said Friday. The U.S. District Court in Baltimore rejected AstraZeneca’s lawsuit, granting a motion from both Sicor and the FDA for a summary judgment, meaning the court found the facts of the case clear enough to rule without going through oral arguments in a hearing. The suit was filed Feb. 5 by British drug maker Zeneca, which bought Sweden’s Astra AB for $40 billion in April, creating the world’s largest drug firm, AstraZeneca. “We have always maintained that this lawsuit was without merit and was simply a continuation of Zeneca’s attempt to block our generic product from the marketplace,” said Frank Becker, chief operating officer at Sicor. AstraZeneca’s lawsuit against the FDA was its second legal challenge to Sicor’s propofol, a generic version of Diprivan, which is an anesthetic drug with hypnotic properties used in intensive care units. Last year, Zeneca also filed a patent infringement suit that it later withdrew, Sicor said. The Baltimore suit against the FDA sought to reverse the agency’s approval of propofol, which was announced in January. Sicor said it began shipping propofol April 16.

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