Monday, October 19, 2009
FDA
FDA approves Crestor for younger patients with familial hypercholesterolemia.The AP (10/16) reported that "the Food and Drug Administration approved AstraZeneca PLC's cholesterol drug Crestor [rosuvastatin] for use by children and teenagers with a genetic disease" called heterozygous familial hypercholesterolemia. The condition "affects 10 million people worldwide, and causes high levels of...LDL cholesterol." HeartWire (10/16, O'Riordan) reported that "the approval is based on data from the Pediatric Lipid Reduction Trial of Rosuvastatin (PLUTO), a 12-week randomized, controlled trial that examined the safety and efficacy of rosuvastatin in 177 pediatric familial hypercholesterolemia patients."
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