ABBOTT PARK, Ill., June 30, 1999 -- Abbott Laboratories announced today it has received U.S. Food and Drug Administration (FDA) approval for Norvir (ritonavir) soft-gelatin capsules. Norvir is a protease inhibitor indicated in combination with other antiretroviral medications for the treatment of HIV infection. Norvir soft-gelatin capsules require refrigerated storage between 36-degrees F to 46-degrees F until dispensed to patients. Refrigeration by patients is recommended, but not required, if used within 30 days and stored below 77-degrees F. Norvir is approved for twice-daily use and should be taken with food, if possible. Norvir soft-gelatin capsules were also approved for marketing in Switzerland in June.
The approval of Norvir soft-gelatin capsules follows intense reformulation work at Abbott after an announcement in July 1998 that a new crystalline structure of ritonavir, which affected how the semi-solid capsule dissolved, would interrupt the production of Norvir semi-solid capsules.
"Bringing Norvir capsules back to patients has been our top priority throughout the past year and we appreciate the patience and understanding we've received from the community as we have worked on the reformulation," said John Leonard, M.D., vice president, pharmaceutical development at Abbott Laboratories. "We also appreciate the efforts regulatory agencies worldwide have made in working closely with us on this formulation throughout the past year."
The soft-gelatin capsule has undergone a number of tests to ensure its stability. Norvir liquid has allowed patients to continue therapy during the period of time when capsules were not available. New Norvir soft-gelatin capsules will be available in U.S. pharmacies beginning next week.
"The availability of the new Norvir soft-gelatin capsules will be welcome news for many patients," said Cal Cohen, M.D., research director, Community Research Initiative of New England. "The twice-daily dosing with Norvir is important. Also, patients choosing to switch from Norvir liquid to the new capsules should experience a relatively smooth transition."
Norvir is indicated in adults in combination with other antiretroviral agents for the treatment of HIV infection. This indication is based on the results ion in both mortality and AIDS-defining clinical events. Norvir also has been approved by the FDA for use in children between the ages of 2 and 16 based on safety and pharmacokinetic data.
Norvir is not a cure for HIV infection. People treated with Norvir may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections. Norvir may not be right for everyone, including people with liver disease, hepatitis or hemophilia. Redistribution/accumulation of body fat has been observed in patients receiving protease inhibitors. Elevated blood sugar levels have been reported in patients taking protease inhibitors. Allergic reactions ranging from mild to severe have been reported. Pancreatitis has been observed in patients receiving Norvir therapy, including those who developed high triglycerides. 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. Norvir should not be used with certain medications including some non-sedating antihistamines, sedative hypnotics, anti-arrhythmics or ergot alkaloid preparations. Patients should talk with their physician or pharmacist or refer to the Norvir full prescribing information, available on the Web at http://www.rxabbott.com/product/nor/norpi.htm.
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