Allergan Gets FDA Acceptable For Filing Letter For Generic Xifaxan ANDA

(RTTNews) - Allergan plc (AGN) said it has received an Acceptable for Filing letter from the U.S. Food and Drug Administration for its Abbreviated New Drug Application or ANDA seeking approval to market Rifaximin Tablets, 550 mg.

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

Allergan said that based on available information, it believes it is the "first applicant" to file an ANDA for the generic version of Xifaxan 550 mg. Should its ANDA be approved, the company may be entitled to 180 days of generic market exclusivity.

According to IMS Health data, for the 12 months ending December 31, 2015, Xifaxan 550 mg had total U.S. sales of about $975 million.