Recent Changes to Norvir (ritonavir) Product Labeling

10/9/2003

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. The new information is summarized in the Portable Document Format (pdf) file linked below.

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Please refer to the complete revised package insert for further details.

The revised label is available at
www.fda.govhttp://www.accessdata.fda.gov/drugsatfda_docs/label/ 2003/20659slr030,20945slr013_norvir_lbl.pdf

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration