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)...
You may also be interested in...
2007 NME Prospects Plentiful For Wyeth, Novartis – Other Firms Fall Short
The year 2007 holds the potential to fatten Wyeth's new drug lineup: after a lean 2006, when no Wyeth new molecular entities were approved, the company leads the industry in potential NME approvals for the coming year
Scotland's MGB Plots Phase III For Promising Antibacterial
With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.
AstraZeneca Vaccine May Only Gain EU Approval In Under 70s
AZ and the EU are at loggerheads over supplies of the COVID-19 vaccine. On top of that, its marketing authorization will present dilemmas.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: