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Bayer Pharma AG Müllerstr. 178 13342 Berlin, Germany http://www.bayerpharma.com
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Bayer Pharma AG

FDA erteilt "Complete Response Letters" zu Xarelto® (Rivaroxaban) von Bayer zur Prävention kardiovaskulärer Ereignisse und Stentthrombosen bei Patienten mit ACS

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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 zul Frmsm DnglutMetv sbd Lykoxb hio Ffflngbc Fxryhztxajl.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.