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BANGKOK, 21 August 2009 (NNT) – The Food and Drug Administration (FDA) is going to register anti-H1N1 drug Oseltavimir for children produced by the Government Pharmaceutical Organization (GPO). The registration is expected to be completed in the next 6 months.
FDA Secretary-General Dr Pipat Yingseree stated that the organization was expediting the registration of the 45-milligram version of Oseltamivir for children. He said the FDA was working on documents on the stability of the drug and there would be no problems in the registration process as Oseltamivir for children had the same formula as the anti-H1N1 drug for adults.
The doses of Oseltamivir for children are 30 and 45 milligrams while Oseltamivir for adults is 75 milligrams.
Roche Thailand was selected by the FDA to produce the 45-milligram Oseltamivir.