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Allergan (AGN) recieves FDA Acceptable for Filing Letter for Generic XIFAXAN® ANDA

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Additional Information

Additional Relevant Details XIFAXAN is 550mg rifaximin tablets, designed to treat IBS-D and reduce the risk of overt hepatic encephalopathy.  

Based on available information, Allergan believes it is the "first applicant" to file an ANDA for the generic version of XIFAXAN® 550 mg and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
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Occurred on:
Feb 29, 2016
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Related Keywords Abbreviated New Drug Application, Rifaximin, Irritable Bowel Syndrome, Generic Drug, Fda Approval, Hepatic Encephalopathy