Allergan received an 'acceptable for filing' letter from the FDA for its abbreviated new drug application seeking approval to market Rifaximin Tablets.
Here are four notes:
1. Allergan's product is a generic version of Valeant Pharmaceuticals' XIFAXAN (rifaximin).
2. Valeant Pharmaceuticals' XIFAXAN is indicated for the treatment of irritable bowel syndrome with diarrhea in adults and for the reduction in risk of overt hepatic encephalopathy recurrence in adults.
3. Allergan believes it is the first applicant to file an abbreviated new drug application for the generic version of XIFAXAN.
4. Allergan is a global pharmaceutical company focusing on development for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic market categories.