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Regarding the assertion that ( REBYOTA TM is an FDA-approved therapeutic option for some patients who may not be eligible for treatment with ZINPLAVA TM due to patient population restrictions (for example, high-risk patients) or contraindications (for example, history of congestive heart failure [CHF]), and that there is no evidence that REBYOTA TM poses an increased risk of serious AEs in patients with a history of CHF, the applicant cited a retrospective study of REBYOTA TM reported by Feuerstadt et al
and melanin level reduced by 3.25% after 4 weeks of use