Use of the affected product can potentially lead to underdosing or overdosing due to non-uniform distribution of cyclosporine.
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Vamorolone is a first-in-class dissociative steroidal drug that retains the anti-inflammatory activity of corticosteroids but with a novel mechanism of action.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
Zolgensma is an adeno-associated virus vector-based gene therapy.