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Search results for samidorphan in Note (approximate match)
Showing 1 - 1 of 1 results
Status:
US Approved Rx
(2021)
Source:
NDA213378
(2021)
Source URL:
First approved in 2021
Source:
NDA213378
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Samidorphan, which was developed by Alkermes, is an opioid receptor antagonist that has been co-formulated with olanzapine into a single-dose oral tablet to mitigate the risk of weight gain while providing the therapeutic effect of olanzapine. In June 2021, the Food and Drug Administration (FDA) approved Lybalvi (olanzapine/samidorphan) for indications including treatment of adults with schizophrenia and/or bipolar I disorder (acute manic episodes or acute episodes with mixed features).