Abbott Laboratories Receives European Commission Marketing Authorization For Reformulated Norvir(R) (Ritonavir) Capsules

Abbott Laboratories announced today it has received marketing authorization from the European Commission for Norvir(R) (ritonavir) soft capsules. Norvir is a protease inhibitor indicated in combination with other antiretroviral medications for the treatment of HIV infection. The approval of Norvir capsules follows intense reformulation work at Abbott after an announcement in July 1998 that a new crystalline structure of ritonavir, that affected how the semi- solid capsule dissolved, would interrupt the production of Norvir semi-solid capsules. "Bringing Norvir capsules back to patients has been a top priority for Abbott throughout the past year and we appreciate the patience and understanding we have received from the HIV community worldwide as we have worked on the reformulation," said William G. Dempsey, senior vice president, international operations at Abbott Laboratories. "We also appreciate the efforts that regulatory agencies worldwide have made in working closely with us on this reformulation throughout the past year." The soft capsule has undergone a number of tests to ensure its stability. Norvir oral solution has allowed patients to continue therapy during the period of time when semi-solid capsules were not available. New Norvir soft capsules will be available immediately in countries where pricing approval is not required. Norvir soft capsules require refrigerated storage between 2 degrees C and 8 degrees C until dispensed to patients. Refrigeration by patients is recommended, but not required, if used within 30 days and stored below 25 degrees C. Norvir is a highly potent inhibitor of HIV protease and has been shown to improve survival in patients with HIV when combined with other antiretroviral agents. More recently, Norvir has been shown to reduce viral load below the level of detection when used in combination with other protease inhibitors and administered twice daily. ots Original Text Service: Abbott Laboratories Internet: Contact: Media, Laureen Cassidy, 847-938-7743, or Financial, John Thomas, 847-938-2655, both of Abbott Laboratories Company News On-Call: or fax, 800-758-5804, ext. 110328 Web site:

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