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Business Editors/Health/Medical Writers
HAYWARD, Calif.–(BUSINESS WIRE)–May 28, 2003
IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the United States Food and Drug Administration (FDA) has accepted the Company’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of SR(R) (Bupropion Hydrochloride) 200mg Tablets. GlaxoSmithKline (Glaxo) markets SR(R) for the treatment of depression. U.S. sales of SR(R) 200mg Tablets were approximately $46 million in the twelve months ended December 31, 2002, according to IMS Health. Glaxo received FDA approval of this product in June 2002.
IMP
A recent meta-analysis of anti-obesity medications pooled the results of three double-blind, placebo-controlled trials of bupropion. It confirmed the efficacy of bupropion given at 400 mg per day for treating obesity. Over a period of 6 to 12 months, weight loss in the bupropion group (4.4 kg) was significantly greater than in the placebo group (1.7 kg). The same review found the differences in weight loss between bupropion and other established weight-loss medications, such as sibutramine, orlistat and diethylpropion, to be statistically insignificant.[38]