sexta-feira, maio 27, 2005

FDA em vias de aprovar tipranavir

Se tudo correr bem na EMEA, prevê-se a AIM do TPV em Portugal no Outono deste ano. Até lá, a Boehringer fornecerá o TPV gratuitamente aos hospitais portugueses através de Autorizações de Utilização Especial (AUEs).

FDA advisory panel says yes to tipranavir (TPV)

The United States Food and Drug Administration’s Antiviral Drugs Advisory Panel voted 11-3 in favour of accelerated approval for the new protease inhibitor tipranavir (Aptivus) after public hearings yesterday in Washington DC.

Tipranavir is being recommended for approval in protease inhibitor-experienced HIV-positive patients, although the final labelling and approval must be decided by the FDA by June 22nd. The panel voted to recommend a twice daily dose of 500mg of tipranavir boosted by 200mg of ritonavir, as studied in phase III trials of the drug.

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