Phase III MINISTONE-2 data are consistent with known safety profile of Xofluza (baloxavir marboxil) in children and show comparable efficacy to oseltamivir
In 2006, former GSIS president and general manager Winston Garcia entered into an agreement with pharmaceutical company Unilab to buy Oseltamivir, a medicine used to treat avian flu.
Baloxavir better reduced viral load at day 2, compared with oseltamivir and placebo, but there was a similar alleviation of symptoms between both groups.
The approval was based on results from the phase III Capstone-1 study of a single-dose of Xofluza compared with placebo or oseltamivir 75mg, twice daily for five days, and also results based on a placebo-controlled phase II study.
The time to symptom alleviation was similar for baloxavir and oseltamivir. Greater reductions in viral load were seen with baloxavir versus placebo or oseltamivir one day after initiation of the regimen.
THE FOOD AND DRUG ADMINISTRATION has approved the first generic version of Tamiflu (oseltamivir phosphate), a medication for the treatment of influenza A and B.
Treatment of influenza virus infection with oral oseltamivir reduces time to alleviation of symptoms in adults and children by approximately one day compared with placebo.
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