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Drugs Approved by the FDA

Drug Name: Norvir (ritonavir) soft-gel capsules

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Abbott Laboratories
Approval Status: Approved June 1999
Treatment for: Immunology/Infectious Diseases

General Information

Norvir soft-gelatin capsules (new formulation) have been approved for the treatment of HIV infection. Norvir is a protease inhibitor indicated in combination with other antiretroviral medications for the treatment of HIV infection. The soft-gel capsules required refrigerated storage until dispensed to patients. Norvir is approved for twice-daily use and should be taken with food, if possible.

Clinical Results

Taken in combination with other antiretroviral medications for the treatment of HIV infection, this indication for Norvir is based on the results from a study in patients with advanced HIV disease that showed a reduction in both mortality and AIDS-defining clinical events. Norvir has also been approved by the FDA for use in children between the ages of 2 and 16 based on safety and pharmacokinetic data.

Side Effects

Common adverse reactions include fatigue, vomiting, diarrhea, loss of appetite, abdominal pain, taste disturbance, tingling sensation or numbness in the hands, feet, or around the lips, headache and dizziness.


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Drug listing last updated on June 20, 2008

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