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12:00 AM
Dec 19, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Asacol mesalamine regulatory update

FDA granted Warner Chilcott's request in a Citizen's Petition that the agency apply previously determined requirements to demonstrate bioequivalence to ANDA applications for generic versions of its Asacol mesalamine and Asacol HD to treat ulcerative colitis (UC). Last year, FDA granted the company's request in a Citizen's Petition to require that applications for generics include data from comparative dissolution testing, which would be considered in addition to comparative pharmacokinetic studies to demonstrate bioequivalence, but denied its request to...

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