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.”
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