
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is a drug used to treat severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women. FDA has determined the Risk Evaluation and Mitigation Strategies (REMS) programs for the drug is no longer necessary as the benefits outweigh the risks of complications.
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