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| |  FDA Approves New Dose Of Wellbutrin SR (Bupropion) New Option May Simplify Dosing for Treatment of Depression RESEARCH TRIANGLE PARK, NC -- June 18, 2002 -- The US Food and Drug Administration approved for marketing today a 200mg formulation of the antidepressant Wellbutrin SR® (bupropion HCl) Sustained-Release Tablets. The 200mg tablet provides patients who currently take 400mg/day of Wellbutrin SR with a more convenient dosage option that reduces the number of tablets required daily. Previously, patients had to take two 100mg sustained-release tablets twice a day to achieve the maximum dose of 400mg/day that is required to be given in two separate doses. The new 200mg Wellbutrin SR tablet has demonstrated bioequivalence to two 100mg sustained-release tablets, making it especially attractive to providers and patients who currently rely upon a total of 400 mg/day as the most effective total daily dose to treat depression. The 200mg tablet will be available at pharmacies by mid-July, joining two existing doses: 100mg and 150mg sustained-release tablets. "The opportunity to have additional dosage options to prescribe often translates into a benefit for patients," says Norman Sussman, MD, Clinical Professor of Psychiatry at New York University. "The new dose formulation of Wellbutrin SR will give patients who are taking 400mg per day the option to decrease the number of tablets they take each day." "There are a substantial number of patients who benefit from Wellbutrin SR at 400mg a day, so we believe the new 200mg formulation will be welcomed by patients and their doctors," said Jack Modell, MD, Senior Director of Clinical Development, Depression, GlaxoSmithKline. "As a company, we are committed to advancing treatment options in the psychiatry therapeutic area, both by developing new products and by improving upon existing ones." Wellbutrin SR (bupropion HCl) Sustained-Release Tablets are contraindicated in patients who have or have had a seizure disorder, patients being treated with Zyban (bupropion HCl) Sustained-Release Tablets or any other medications that contain bupropion, patients with a current or prior diagnosis of bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines), and patients who are currently taking or have recently taken (within 14 days) a monoamine oxidase (MAO) inhibitor. In managing a patient’s depressive episode, a physician should be aware that Wellbutrin SR may cause seizures in a dose-related manner. Similar to other antidepressants, the incidence of seizure is approximately 0.1% at the recommended daily dose of 300mg. The incidence increases to approximately 0.4% at the maximum daily dose of 400mg. To reduce the risk of seizures, refer to Warnings in the Prescribing Information for patient selection considerations, including concomitant medications and dosing recommendations. When treating patients with severe hepatic cirrhosis, extreme caution should be exercised and a reduced dosage and/or frequency is required to avoid accumulation. GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. SOURCE: GlaxoSmithKline
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