Octapharma USA Inc
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Latest From Octapharma USA Inc
How Did US FDA Get Octapharma To Drop Its Suit?
Company sought court order to vacate agency’s approval of the fibrinogen products of three blood centers, saying they were wrongly exempt from clinical trials required for Octapharma’s Fibryga.
Grifols Aims For Largely Untapped Market With Successful Fibrinogen Deficiency Study
The Phase III trial of BT524 produced positive topline results in patients with acquired fibrinogen deficiency, potentially making it the first fibrinogen concentrate to win US FDA approval for that indication.
FDA’s Disparate Treatment Of Fibrinogen Products ‘Defies Logic,’ Octapharma Contends
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.
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