The U.S. Food and Drug Administration committed “egregious errors” when it tentatively approved two generic drug applications, but the agency has the power to fix its mistakes by revoking the approvals, a Washington federal judge ruled Wednesday.
U.S. District Judge Beryl Howell blasted the FDA for tentatively approving Ranbaxy Laboratories Ltd.’s applications to make the first generic versions of Nexium, which treats heartburn, and Valcyte, used after organ transplants.
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