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

1.12.1999, 14:57

ABBOTT PARK, Ill. (PROTEXT) - Abbott Laboratories announcedtoday it has received marketing authorization from the EuropeanCommission for Norvir(R) (ritonavir) soft capsules. Norvir is aprotease inhibitor indicated in combination with otherantiretroviral medications for the treatment of HIV infection. The approval of Norvir capsules follows intense reformulationwork at Abbott after an announcement in July 1998 that a newcrystalline structure of ritonavir, that affected how the semi-solid capsule dissolved, would interrupt the production of Norvirsemi-solid capsules. "Bringing Norvir capsules back to patients has been a toppriority for Abbott throughout the past year and we appreciatethe patience and understanding we have received from the HIVcommunity worldwide as we have worked on the reformulation," saidWilliam G. Dempsey, senior vice president, internationaloperations at Abbott Laboratories. "We also appreciate theefforts that regulatory agencies worldwide have made in workingclosely with us on this reformulation throughout the past year." The soft capsule has undergone a number of tests to ensure itsstability. Norvir oral solution has allowed patients to continuetherapy during the period of time when semi-solid capsules werenot available. New Norvir soft capsules will be availableimmediately in countries where pricing approval is not required. Norvir soft capsules require refrigerated storage between 2degrees C and 8 degrees C until dispensed to patients.Refrigeration by patients is recommended, but not required, ifused within 30 days and stored below 25 degrees C. Norvir is a highly potent inhibitor of HIV protease and hasbeen shown to improve survival in patients with HIV when combinedwith other antiretroviral agents. More recently, Norvir has beenshown to reduce viral load below the level of detection when usedin combination with other protease inhibitors and administeredtwice daily. ots Original Text Service: Abbott LaboratoriesInternet: http://www.newsaktuell.de Contact: Media, LaureenCassidy, 847-938-7743, or Financial, John Thomas, 847-938-2655,both of Abbott Laboratories Company News On-Call:http://www.prnewswire.com/comp/110328.html or fax, 800-758-5804,ext. 110328 Web site: http://www.abbott.com

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