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Feb 20, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Xifaxan rifaximin regulatory update

FDA issued draft guidance for developing generic versions of Salix's 550 mg Xifaxan rifaximin to reduce the risk of hepatic encephalopathy recurrence. The agency recommended companies seeking an ANDA for the 550 mg dose conduct a pair of single-dose, 2-way crossover bioequivalence studies with pharmacokinetic endpoints in healthy volunteers. For the...

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