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FDA Drug Approvals Don't Include Impurities, DC Circ. Rules

By Dorothy Atkins (January 10, 2023, 7:36 PM EST) -- The D.C. Circuit affirmed Tuesday the U.S. Food and Drug Administration's win in Sandoz Inc.'s lawsuit challenging the agency's decision to give rival Sanofi exclusivity to its multiple sclerosis drug, Aubagio, rejecting Sandoz's claim that the FDA already approved the drug's active ingredient as an impurity in another drug....

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