Die US-amerikanische Gesundheitsbehörde FDA (Food and Drug Administration) hat mit einem "Complete Response Letter" zum Zulassungsantrag des oralen Gerinnungshemmers Xarelto® (Rivaroxaban) in einer Dosierung von zweimal täglich 2,5 mg in Kombination mit Standard-Plättchenaggregationshemmung zur Sekundärprävention kardiovaskulärer Ereignisse (kardiovaskuläre Sterblichkeit, Herzinfarkt oder Schlaganfall) bei Patienten mit akutem Koronarsyndrom (ACS) Stellung genommen. Zusammen mit seinem Kooperationspartner Janssen Research & Development, LLC, prüft Bayer den Complete Response Letter der FDA und wird die Fragen der Behörde beantworten.
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