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The FDA has denied approval of the antiobesity drug lorcaserin, according to the New York Times.
The drug is a highly selective agonist of central-nervous-system serotonin receptors.
The Times reports that the FDA's refusal hinged on lorcaserin's association with tumor formation in rats given high doses. The manufacturer announced that the FDA may request more studies "to obtain a more robust assessment of lorcaserin's benefit-risk profile."
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LINK(S):
New York Times story (Free)
Manufacturer's announcement of FDA action (Free)
Journal Watch General Medicine summary and interview on phase II study of lorcaserin from July 2010 (Free)