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FDA Approves New Norvir Tablet for Use - from Abbott
 
 
 
 
Feb.10, 2010
 
Abbott is pleased to announce the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of our protease inhibitor (PI) Norvir® (ritonavir). This new heat-stable formulation can be stored at room temperature and does not require refrigeration, making it more convenient for patients.
 
Norvir Tablet and Meltrex
 
Abbott developed the technology known as Meltrex® that makes the Norvir tablet possible. Even though the Meltrex technology exists in Kaletra® (lopinavir/ritonavir) it took several years and extensive clinical work to develop the Norvir tablet for FDA approval. The time and investment in development were well spent for patients and physicians, and in the coming weeks the Norvir tablet will be available in pharmacies across the country. The new Norvir tablet and the Norvir soft-gelatin capsule both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. All forms of Norvir remain on the market, including the soft-gelatin capsule and liquid.
 
Pricing, Access, and the Norvir Tablet
Abbott will launch the Norvir tablet at the same wholesale acquisition (WAC) price as the soft-gel capsules.
 
To further help patients access this important new formulation of Norvir, Abbott is launching a Norvir co-pay support program, which will be available through Norvir.com. The co-pay program will be available for all formulations of Norvir. Once a patient has paid $25 in co-pays, this program will cover up to $75 per month in patient co-pays within the first 12 months. Certain restrictions may apply.
 
Abbott's patient assistance program will continue to make sure that any patient without prescription coverage can get Norvir for free, regardless of their financial status. The Patient Assistance Program also provides Norvir free of charge to any ADAP-eligible patient on a waiting list, to anyone who has exceeded his or her coverage maximum for annual prescription drug benefits, and to those patients on 400 mg a day or more.
 
Abbott also offers several patient assistance programs that provide Kaletra and Norvir at no cost to patients experiencing financial difficulties. To learn more about other programs assisting patients in need, visit Abbott's Patient Assistance Programs overview online or call Abbott's patient access toll-free number at 1-800-222-6885, option 4.
 
Important Information About Norvir
Do not take Norvir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Do not take Norvir if you have had a serious allergic reaction to any of its ingredients. Some patients taking Norvir may develop liver and pancreas problems, which can cause death. Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. You may develop signs and symptoms of infections that you already have after starting anti-HIV medicines. Please see the Important Safety Information for more details.
 
Important Information About Kaletra
Do not take Kaletra if you are allergic to any of its ingredients, including lopinavir or ritonavir. Do not take Kaletra with certain medicines, as they can cause serious problems, death, or make Kaletra less effective against HIV. Some patients taking Kaletra can develop inflammation of the pancreas and liver problems, which can cause death. Patients may develop changes in heart rhythm, large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or increased bleeding in people with hemophilia. Some patients may develop signs and symptoms of serious infections they already have after starting anti-HIV medicines.
 
If I can provide further information about the Norvir tablet or address any questions you may have, please do not hesitate to contact me.
 
Yours in the cause,
 
Jim Howley
Director, Advocacy and Policy, Abbott
 
 
 
 
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