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FDA Approves Viracept, New Protease Inhibitor

FDA Approves Viracept, New Protease Inhibitor

ROCKVILLE, Md--The FDA has given Agouron Pharmaceuticals clearance to market its protease inhibitor Viracept (nelfinavir mesylate), under the accelerated approval process. Viracept was approved in both adult and pediatric formulations, for the treatment of HIV when antiretroviral therapy is warranted.

The indication is based on analyses of surrogate marker changes in patients who received Viracept in combination with nucleoside analogues or alone for up to 24 weeks. At present, there are no results from controlled trials evaluating the effects of Viracept on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections.

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