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Novartis Tekturna is first renin inhibitor to market

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis has succeeded in making Tekturna (aliskiren, formerly Rasilez) the first renin inhibitor to reach the market. FDA cleared the drug March 5 for treatment of hypertension. The indications section of labeling notes that Tekturna "may be used alone or in combination with other antihypertensive agents. Use with maximal doses of ACE inhibitors has not been adequately studied." Last year, FDA extended the Tekturna user fee date by 90 days (to March) in order to address safety concerns related to the colon (1Pharmaceutical Approvals Monthly January 2007, p. 3)...

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