FDA announces changes to ritonavir package insert

1 November 2003. Related: Antiretrovirals.

Revisions were recently made to the product labeling for Norvir (ritonavir) 100mg soft gelatin capsules and Norvir (ritonavir) 80mg/mL oral solution, marketed by Abbott Laboratories.

The changes address a Phase IV commitment to develop appropriate labeling for patients with hepatic insufficiency. Changes were also made to the Drug Interaction tables, including new information on the co-administration of Warfarin.

Other revisions include minor editorial changes such as renumbering of tables and consolidation of information into specific sections.

Source: NATAP.org