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How Did US FDA Get Octapharma To Drop Its Suit?

 
• By Brenda Sandburg

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.

Path forward
US FDA and Octapharma find 'administrative path forward' to resolve litigation • Source: Shutterstock

Seventeen months after Octapharma USA Inc sued the US Food and Drug Administration to compel the agency to rescind approval of plasma-derived fibrinogen products sponsored by three blood centers, the parties agreed to dismissal of the complaint.

Before the suit was dropped, Octapharma and the agency noted in joint status reports to the court that they were in discussion about an “administrative path forward.” It is unknown...

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