UPDATE 1-Novartis gets final U.S. approval for Exforge
(Adds details)
ZURICH, June 21 (Reuters) - Swiss drugmaker Novartis (NOVN.VX) has received final U.S. approval for its high blood pressure medicine Exforge.
Novartis said on Thursday that the U.S. Food and Drug Administration (FDA) had given the green light to Exforge, which combines the two most commonly prescribed hypertension medicines in one tablet, and that it would be available soon.
The FDA had already granted Novartis tentative approval in December. Exforge was approved in January 2007 in the European Union and has already been made available in nine EU countries, with further launches planned.
The approval comes as a boost to Novartis, which suffered several earnings downgrades from analysts this month after a U.S. court said it would not stand in the way of Teva (TEVA.O) (TEVA.TA) selling a generic version of Novartis's hypertension drug Lotrel.
Exforge is seen as a key near-term sales driver alongside blood pressure treatment Tekturna. Novartis also suffered a setback in February when U.S. regulators requested more data on diabetes drug Galvus, possibly delaying approval of the potential blockbuster by a year.
Exforge combines Novartis's Diovan and Pfizer's (PFE.N) Norvasc (amlodipine besylate) into a single tablet. Novartis said nine out of 10 patients using Exforge reached their hypertension treatment goal in clinical trials.
High blood pressure is a leading risk factor for cardiovascular disease, which is the world's most common cause of death.
((Reporting by Thomas Atkins, editing by Will Waterman
Email: thomas.atkins@reuters.com
Reuters Messaging:
rm://thomas.atkins.reuters.com@reuters.net
Telephone: +41.44.631.7311)) Keywords: NOVARTIS EXFORGE/
(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nL21189726
