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BioMarin’s Kuvan Gets Priority Review in Canada

By Pharmaceutical Processing | June 10, 2009

NOVATO, Calif. (AP) — BioMarin Pharmaceutical Inc. said Wednesday its genetic disorder drug Kuvan will get a priority review by Canadian regulators. The drug treats phenylketonuria, or PKU, a genetic disorder that can cause problems with brain development. It is already approved in the U.S. and had sales of $15.5 million during the first quarter. The priority review means a shortened submission review of 180 days versus the standard 12 months. The company expects to ask for approval during the third quarter, and a decision would likely come in the first half of 2010.

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