ARTICLE | Regulation
Rat Poisoning
February 22, 2010 8:00 AM UTC
FDA's decision not to approve XenoPort Inc.'s Horizant gabapentin enacarbil to treat restless legs syndrome last week is a puzzling application of the precautionary principle.
According to the company and its partner GlaxoSmithKline plc, the agency's main hang-up was a two-year rat study in which some animals developed pancreatic acinar cell tumors...