FDA
announced June 7, 2002 the approval of a supplemental New Drug Application (sNDA)
that allows restricted marketing of Lotronex (alosetron hydrochloride), to treat
only women with severe diarrhea-predominant irritable bowel syndrome (IBS). The
approved sNDA for Lotronex includes a risk management program to ensure patients
and physicians are fully informed of risks and possible benefits of Lotronex.
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