Die US-amerikanische Gesundheitsbehörde Food and Drug Administration (FDA) hat mit "Complete Response Letters" zum Zulassungsantrag des oralen Gerinnungshemmers Xarelto® (Rivaroxaban) in einer Dosierung von zweimal täglich 2,5 mg in Kombination mit Standard-Plättchen-Aggregationshemmung zur Prävention kardiovaskulärer Ereignisse und Stentthrombosen bei Patienten mit akutem Koronarsyndrom (ACS) Stellung genommen.
"Das Ergebnis der Überprüfung des Zulassungsantrags durch die FDA ist enttäuschend für uns. Gemeinsam mit unserem Kooperationspartner Janssen Research & Development, LLC engagieren wir uns weiterhin dafür, Patienten mit akutem Koronarsyndrom in den USA einen zusätzlichen Schutz vor Stentthrombosen und lebensbedrohlichen kardiovaskulären Ereignissen anbieten zu können", sagte Dr. Jörg Möller, Mitglied im Executive Committee xpk Xuvsp RepvzjGydu jgc Eicxpm ush Xislhvxz Plhxyctwbmm.
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"Das Ergebnis der Überprüfung des Zulassungsantrags durch die FDA ist enttäuschend für uns. Gemeinsam mit unserem Kooperationspartner Janssen Research & Development, LLC engagieren wir uns weiterhin dafür, Patienten mit akutem Koronarsyndrom in den USA einen zusätzlichen Schutz vor Stentthrombosen und lebensbedrohlichen kardiovaskulären Ereignissen anbieten zu können", sagte Dr. Jörg Möller, Mitglied im Executive Committee xpk Xuvsp RepvzjGydu jgc Eicxpm ush Xislhvxz Plhxyctwbmm.
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