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Review Period Set for Prezista

05/25/2007

Federal Register Notice: FDA has determined the regulatory review period for Ortho Biotech’s Prezista is 1,253 days for extending a patent which claims the human drug product. Prezista, co-administered with 100 mg ritonavir and with other antiretroviral agents, is indicated for treating HIV infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. To view this notice, click here.

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