June 27, 2007 — The US Food and Drug Administration (FDA) has given the commercial go-ahead to a once-daily medication for hypertension (Exforge, Novartis) that combines the angiotensin receptor blocker (ARB) valsartan with amlodipine, a calcium-channel blocker, Novartis announced.
The approval indication isn't for first-line therapy, according to Novartis; rather, it's for patients with hypertension not controlled by ARB or calcium-channel-blocker monotherapy and for those with dose-limiting side effects on either valsartan or amlodipine. Exforge was approved by regulators in the European Union in January 2007.
http://www.pharma.us.novartis.com/newsroom/pressReleases/releaseDetail.jsp?PRID=2025
http://www.fda.gov/cder/whatsnew.htm
http://www.fda.gov/cder/foi/label/2007/021990lbl.pdf
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