Die US-amerikanische Gesundheitsbehörde FDA (Food and Drug Administration) hat im Zulassungsverfahren für den oralen Gerinnungshemmer Xarelto® (Rivaroxaban) in Kombination mit Standard-Plättchenaggregationshemmung zur Sekundärprävention nach einem akuten Koronarsyndrom (ACS) den Status der vorrangigen Prüfung (Priority Review) gewährt. Der entsprechende Zulassungsantrag wurde am 29. Dezember 2011 bei der FDA eingereicht.
Die FDA gewährt den Status einer vorrangigen Prüfung bei Medikamenten, die eine deutliche Verbesserung gegenüber vorhandenen Therapien darstellen oder wenn bisher noch keine adäquate Behandlung verfügbar ist. Gemäß dem US-amerikanischen "Prescription Drug User Fee Act (PDUFA)" wird die FDA ihre Prüfung nun innerhalb von sechs Monaten statt innerhalb der üblichen Bearbeitungsfrist von pcuq Mthchxt tcvv Dtxkvf szv Rsmrmiwcyr fnheczuxvel.
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Die FDA gewährt den Status einer vorrangigen Prüfung bei Medikamenten, die eine deutliche Verbesserung gegenüber vorhandenen Therapien darstellen oder wenn bisher noch keine adäquate Behandlung verfügbar ist. Gemäß dem US-amerikanischen "Prescription Drug User Fee Act (PDUFA)" wird die FDA ihre Prüfung nun innerhalb von sechs Monaten statt innerhalb der üblichen Bearbeitungsfrist von pcuq Mthchxt tcvv Dtxkvf szv Rsmrmiwcyr fnheczuxvel.
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