Allergan Announces Receipt Of FDA Acceptable For Filing Letter For Generic XIFAXAN ANDA

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The FINANCIAL — Allergan plc on February 29 announced that the Company has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) seeking approval to market Rifaximin Tablets, 550 mg.

Allergan’s ANDA product is a generic version of Valeant Pharmaceuticals’ XIFAXAN (rifaximin) 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.

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, according to Allergan.

For the 12 months ending December 31, 2015, XIFAXAN 550 mg had total U.S. sales of approximately $975 million, according to IMS Health data.

 

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