Angiomax Gains Second Label Expansion For 2005; FDA Requests Patient Registry
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The Medicines Company's anticoagulant Angiomax cleared FDA Nov. 30 for use in patients undergoing percutaneous coronary intervention (PCI) who either have or are at risk for heparin-related complications
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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...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
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