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FDA’s Disparate Treatment Of Fibrinogen Products ‘Defies Logic,’ Octapharma Contends

 
• By Brenda Sandburg

Suit says FDA wrongly classified the fibrinogen products of three blood centers as ‘blood components’ exempt from clinical trials while classifying Octapharma’s Fibryga as a ‘blood derivative’ subject to clinical studies.

Blood cells
US FDA sued over its classification of fibrinogen blood products • Source: Shutterstock

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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