Octapharma USA Inc is seeking an injunction to vacate the US Food and Drug Administration’s approval of plasma-derived fibrinogen products sponsored by three blood centers. It claims they should have undergone clinical testing as the agency required for approval of Octapharma’s Fibryga (human fibrinogen concentrate).
In a 14 September suit filed in the US District Court for the District of Columbia, Octapharma says the...
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