500 mg saquinavir (Invirase) approved in US

A new 500 mg tablet formulation of the HIV protease inhibitor, Invirase (saquinavir mesylate) was approved by the FDA in the US, on December 17, 2004, a. The dosage and administration for Invirase in adults (over the age of 16 years) is 1000 mg twice a day (taken as either two 500 mg tablets or five 200 mg capsules) in combination with ritonavir 100 mg twice a day. The new tablet formulation reduces the pill burden compared to the capsule formulation.

Ritonavir should be taken at the same time as Invirase and both drugs should be taken within 2 hours after a meal

PDF copy of the complete labeL:


In Europe, regulatory review is ongoing. At the earliest, approval of the 500 mg tablet formulation of Invirase can be expected as of the end of May 2005.

Although the US price for  Invirase 500mg has not been announced, it is expected to be in-line with the current  Invirase formulation.

For further information on this in the UK please contact Rebecca Hunt at Roche on 07786 171 214.

Source: FDA December 17, 2004 online at

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