Abbott Laboratories' Statement Regarding FDA'S DDMAC Letter on Norvir(R) (Ritonavir Capsules) Materials ABBOTT PARK, Ill., June 10 /PRNewswire-FirstCall/ -- Abbott has received a warning letter from the United States Food and Drug Administration's Division of Drug Marketing Advertising and Communications (DDMAC) outlining concerns related to the website and other specified materials for Norvir(R) (ritonavir capsules) Soft Gelatin capsules. FDA's letter addresses two primary concerns. The first pertains to a cost comparison chart describing the daily cost of common anti-retroviral therapies. FDA raised concerns that this chart could be interpreted to imply that Norvir can be used as monotherapy at a sub-therapeutic dose. Abbott developed this chart to respond to concerns regarding Abbott's re-pricing of Norvir and not to promote the use of Norvir as monotherapy at a sub- therapeutic dose. Abbott will modify the materials in accordance with FDA guidance to address these issues. Second, FDA raised concerns about the presentation of risk information in certain materials regarding Norvir. Abbott will work with the FDA to ensure that all Norvir-related materials provide appropriate balance of risk information. About Norvir(3) NORVIR is indicated in combination with other antiretroviral agents for the treatment of HIV infection. This indication 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 for patients who received NORVIR either alone or in combination with other nucleoside analogues. Median duration of follow-up in this study was 13.5 months. Safety Information NORVIR should not be taken if you have had a serious allergic reaction to NORVIR or any of its ingredients. Taking NORVIR with certain drugs could create potential for serious side effects that could be life-threatening. Do not use NORVIR with Cordarone(R), ergotamine, ergonovine, methylergonovine, and dihydoergotamine such as Cafergot(R), Migranal(R), and D.H.E. 45(R) as well as Halcion(R), Hismanal(R), Orap(R), Propulsid(R), Quinidine, Rythmol(R), Seldane(R), Tambocor(TM), Vascor(R) and Versed(R). Particular caution should be used when taking Viagra(R), since the interaction with NORVIR may result in an increase in Viagra-related side effects. Discuss all medicines, including those without a prescription, and herbal preparations (for example, St. John's wort) you are taking or plan to take with your doctor or pharmacist. Pancreatitis and liver problems, which may cause death, have been reported in patients receiving NORVIR. Tell your doctor if you have or have had liver disease such as hepatitis. Varying degrees of cross-resistance among protease inhibitors have been observed. In patients taking protease inhibitors, increased bleeding (in patients with hemophilia) and diabetes/high blood sugar have occurred. Some patients have reported allergic reactions ranging from mild to severe. Changes in body fat have been seen in some patients receiving protease inhibitors. Some patients receiving NORVIR have had large increases in triglycerides and cholesterol. The most commonly reported side effects of moderate severity are: feeling weak or tired, nausea, vomiting, diarrhea, loss of appetite, abdominal pain, changes in taste, tingling feeling or numbness in hands or feet or around the lips, headache, and dizziness. NORVIR does not cure HIV infection or AIDS and does not reduce the risk of passing of HIV to others. The long-term effects of Norvir are unknown. Norvir has not been shown to reduce the risk of transmitting HIV to others through sexual contact or blood contamination. For more information, including Norvir (ritonavir) full prescribing information, please visit http://www.norvir.com/ . Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 70,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ . DATASOURCE: Abbott Laboratories CONTACT: Media, Melissa Brotz, +1-847-935-3456, cellular, +1-847-772-2761, Jennifer Smoter, +1-847-935-8865, cellular, +1-847-772-4631, or Financial Community, John Thomas, +1-847-938-2655, all of Abbott Laboratories Web site: http://www.norvir.com/ http://www.abbott.com/ Company News On-Call: http://www.prnewswire.com/comp/110328.html

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