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 FDA Information - November 20, 2008
| GlaxoSmithKline announces that the U.S. Food and Drug Administration (FDA) has approved Arranon (nelarabine) Injection, a chemotherapy agent, for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. According to GlaxoSmithKline, this use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted | | Following Senate approval, The House has passed a bill requiring colored contact lenses be dispensed by eye-care professionals, under authority of the Food and Drug Administration. In 2003, the FDA changed the classification of noncorrective colored contact lenses from medical devices to cosmetic devices | | The Center for Science in the Public Interest says the Food and Drug Administration has not taken action to stop what they call "deceptive labeling." CSPI claims many food labels currently on shelves exaggerate the presence of healthy ingredients. The group claims some food manufacturers are "tricking" health-conscious consumers | | The Food and Drug Administration is considering making a "do-it-yourself" AIDS test available over-the-counter. The OraQuick Advance test is already widely available in health clinics and doctors' offices. Supporters of home kits say more people will get tested and get treatment sooner, if infected. However, concerns have been raised about whether a doctor or counselor should be nearby if people find out they are HIV-positive | | A warning about a specific brand of blood glucose meters has been issued by Federal regulators. The Food and Drug Administration reports meters made by Abbott Diabetes Care in Alameda, California, can unintentionally be switched from one unit of measurement to another, causing patients to interpret the reading incorrectly. An inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia | |
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