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Article: U.S. FDA Approves INVIRASE(R) Boosted With Ritonavir for Use in Treatment of HIV/AIDS; New Dosing Strategy Offers Potent Option in Combination with Other Anti-HIV Drugs.
- Article from:
- PR Newswire
- Article date:
- January 6, 2004
CopyrightCOPYRIGHT 2004 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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NUTLEY, N.J., Jan. 6 /PRNewswire/ -- Roche today announced U.S. Food and Drug Administration (FDA) approval of its protease inhibitor INVIRASE(R) (saquinavir mesylate 1000 mg) for use with ritonavir (100 mg) in combination regimens for the treatment of HIV infection. This new dosing strategy increases ("boosts") blood levels of saquinavir to enable twice-daily dosing and eliminates the inadequate drug levels associated with use of INVIRASE alone.
FDA approval of Roche's supplemental New Drug Application (sNDA) for INVIRASE was based on data which showed that INVIRASE 1000 mg with ritonavir 100 mg twice-daily provides similar to or greater levels of saquinavir ...