quarta-feira, março 02, 2005
Duas novas formulações recebem aprovação europeia
A positive marketing opinion has been granted in Europe to a new formulation of a protease inhibitor, and European marketing approval has been granted to a once-daily “nuke” combination pill.
A new formulation of the protease inhibitor saquinavir has received a positive marketing opinion from the European Committee for Medicinal Products for Human Use. The new 500mg formulation of Roche’s hard gel saquinavir (Invirase) has a twice-daily dose of two tablets, boosted by 100mg of ritonavir. The previous dose of boosted-Invirase was five 200mg capsules twice-daily, each dose taken with 100mg of ritonavir.
Marketing approval has been granted by the European Commission for Gilead’s Truvada, a co-formulation of the nucleoside analogue FTC (emtricitabine, Emtriva) and the nucleoside analogue tenofovir (Viread). Truvada is taken once daily and includes 300mg of tenofovir and 200mg of FTC in a single pill.