New Drug Application for Rivaroxaban in the U.S.: Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
16-Jul-2009 -
Bayer Schering Pharma AG, Germany, announced that its partner, Ortho-McNeil, does not expect to submit its complete response to the U.S. Food and Drug Administration (FDA) until the fourth quarter of this year, at the earliest.
“We are fully convinced of the positive risk-benefit profile of ...
Bayer HealthCare
Bayer Schering
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