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NitroMed’s BiDil XR Will Use Elan Delivery Technology Under Recent Deal

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

NitroMed aims to have a regulatory and development plan for an extended-release formulation of its heart failure combo therapy BiDil (isosorbide dinitrate/hydralazine) by the middle of the year, the firm told 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...

Spectrum’s Iso-Vorin Could Clear FDA For Osteosarcoma By First Quarter

The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.

Thelin's Third "Approvable" Letter Recommends Additional Clinical Trial

Encysive may be forced to make "significant reductions" to infrastructure and workforce, firm says June 15.

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