A 500mg tablet formulation of Roche’s Invirase (saquinavir) has been approved for prescription in the United States, the US Food and Drug Administration announced on December 17th.
The new tablet is designed for dosing with ritonavir, and the approved dosage is 1000mg twice daily after meals with 100mg of ritonavir taken at the same time. The 500mg tablet cuts the pill burden substantially for people taking saquinavir, and is also better tolerated than the Fortovase formulation of saquinavir.
The 500mg tablet is already available on a named patient basis in the UK for patients taking who may benefit from a protease inhibitor with a low pill burden, and is expected to receive European approval for prescription in the first half of 2005.