Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
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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