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Updates to the darunavir (Prezista®) package insert, specifically sections: 6 Adverse Reactions, 12.4 Microbiology, 14 Clinical Studies and were approved on Oct. 19, 2011, to include results from the 192-week safety, resistance and efficacy data from study TMC114-C211, "A randomized, controlled, open-label Phase 3 trial comparing darunavir/ritonavir 800/100 mg once daily versus lopinavir/ritonavir 800/200 mg per day (given as a twice daily or as a once daily regimen) in antiretroviral treatment-naïve HIV-1-infected adult subjects."

FDA Notifications

December 1, 2011

Updates to the darunavir (Prezista®) package insert, specifically sections: 6 Adverse Reactions, 12.4 Microbiology, 14 Clinical Studies and were approved on Oct. 19, 2011, to include results from the 192-week safety, resistance and efficacy data from study TMC114-C211, "A randomized, controlled, open-label Phase 3 trial comparing darunavir/ritonavir 800/100 mg once daily versus lopinavir/ritonavir 800/200 mg per day (given as a twice daily or as a once daily regimen) in antiretroviral treatment-naïve HIV-1-infected adult subjects."

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