![]() Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients. orphan drug and FDA breakthrough therapy designations and was approved under the FDA's accelerated approval pathway based on the change from baseline in anti-factor Xa activity in healthy volunteers. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals' Andexxa, the first factor Xa inhibitor antidote indicated for patients treated with rivaroxaban (Xarelto) and apixaban (Eliquis), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.Īndexxa (coagulation factor Xa, inactivated-zhzo) received both U.S.
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