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NME "Approvables" Outnumber Approvals Six To Two In October

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

An "approvable" action was three times more likely than approval for the new molecular entities with user fee goals in October, according to an analysis by Pharmaceutical Approvals Monthly.

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Approvals In Brief

Aptivus clears FDA for HIV: Labeling for Boehringer Ingelheim's HIV agent Aptivus (tipranavir) advocates use of genotypic or phenotypic testing and/or treatment history to help guide therapy. The non-peptidic protease inhibitor received accelerated approval June 22 for use with Abbott's Norvir (ritonavir) for "treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors." Accelerated approval was based on response rate in two 24-week, open-label Phase III trials; to support full approval, BI will submit 48-week data from two ongoing Phase III studies by Sept. 30, 2006. Postmarketing studies will look at therapeutic drug monitoring and drug-drug interactions. Like other protease inhibitors, Aptivus has an extensive interaction profile: it is either contraindicated or "not recommended" for concomitant use with 19 drugs...

Ranexa Could Be First Approval For First-Line Angina With MERLIN Trial

CV Therapeutics’ Ranexa could receive the first approval for first-line treatment of chronic angina if a new outcomes trial does not detect a trend towards death or arrhythmia, the company said.

Novo Nordisk Levemir gets CPMP okay

Novo Nordisk expects European approval of Levemir (insulin detemir) "within the coming months" following a positive opinion from the EU's Committee on Proprietary Medicinal Products, the company announces Feb. 27. European launch is slated for second-half 2004. The long-acting insulin analog was deemed "approvable" for treatment of diabetes by FDA Oct. 7, 2003, pending resolution of "certain clinical issues" (1Pharmaceutical Approvals Monthly Nov. 1, 2003, p. 3)...

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