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July 21, 2009

FDA Clears Novartis Medication as Initial Therapy for Blood Pressure

  • FDA approved Novartis’ Tekturna HCT® tablets as initial therapy for hypertensive patients likely to need multiple blood pressure medications. The drug is a single-pill combination of the direct renin inhibitor, aliskiren (Tekturna/Rasilez), and the diuretic hydrochlorothiazide (HCT).

    Tekturna HCT was first approved in the U.S. in January 2008 as a second-line treatment for high blood pressure, and in the EU in January 2009. Novartis says that it is also developing other single-pill aliskiren combinations including a combination with Diovan (valsartan) and one with amlodipine.

    The single-agent direct renin inhibitor, Tekturna, was first approved in March 2007 and is now available in over 70 countries. Most recently in July 2009 it entered Japan.



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