Tuesday, July 24, 2012
Cardiovascular and Renal Drugs Advisory Committee Meeting
Cardiovascular and Renal Drugs Advisory Committee Meeting
Committee Meeting September 14, 2012 8:00 a.m. to 5:00 p.m.
Agenda: The committee will discuss new drug application (NDA) 203446, imatinib mesylate, submitted by Novartis Pharmaceuticals Corp., as adjunctive therapy for the treatment of pulmonary arterial hypertension (WHO Diagnostic Group 1), to improve exercise capacity and cardio-pulmonary hemodynamics in patients who remain symptomatic despite treatment with two or more approved vasodilator therapies (“vasodilator therapies” refer to medicines used to dilate blood vessels and thereby reduce resistance to blood flow).
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