FDA approved a 200 mg formulation of the antidepressant Wellbutrin SR® sustained-release tablets

On June 18, 2002, the FDA approved a 200 mg formulation of the antidepressant Wellbutrin SR[R] (bupropion HCl) sustained-release tablets. The new tablet means that patients taking 400 mg per day will now need to take one tablet twice a day, instead of two 100 mg tablets twice a day. The 200mg tablet will be available at pharmacies by mid-July, joining two existing doses: 100 mg and 150 mg sustained-release tablets. According to Jack Model, MD, senior director of clinical development, depression, at GlaxoSmithKline, "There are a substantial number of patients who benefit from Wellbutrin SR at 400 mg a day, so we believe the new 200 mg formulation will be welcomed by patients and their doctors." For payers, there may be cost advantages for some patients depending on the price at which they obtain the 200 mg tablet. When tablet costs are similar, taking fewer tablets can mean significant savings. In addition, the flexibility afforded by the new dosage form may give Wellbutrin competitive advantage over more expensive antidepressants for some patients. Information: Holly Russell for GlaxoSmithKline, (919) 483-2839.

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