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Jun 25, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

PA32540 regulatory update

Pozen said that FDA told the company a Phase I trial of PA32540 does not satisfy an agency request to show bioequivalence to enteric-coated (EC) 325 mg aspirin prior to an NDA submission. PA32540 is a tablet containing 325 mg aspirin surrounded by an immediate-release coating of 40 mg...

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