CRDACCardiovascular and Renal Drugs Advisory Committee
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The joint meeting of the CRDAC and DSRMAC convened to discuss the risks and benefits of Epoetin alfa in the treatment of the anemia of CRE This re-analysis of data was prompted by safety concerns arising from the results of clinical studies such as the Normal Hematocrit Cardiac Trial (NHCT) (Besarab et al., 1998) and the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study (Singh et al., 2006).
M2 PHARMA-February 24, 2012-FDA's CRDAC advises approval of Northera for NOH(C)2012 M2 COMMUNICATIONS
Biopharmaceutical development company Chelsea Therapeutics International ltd (Nasdaq:CHTP) reported on Thursday that 7-4 votes, with 1 abstention and 1 non-vote, from the US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC), recommend approval of Northera (droxidopa).