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However, the FDA is giving compounders a 60- or 90-day wind-down period, depending on the type of compounding facility, to avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition. The agency intends to exercise enforcement discretion (i.e., not take enforcement action) until April 22 for compounding performed by state-licensed pharmacies and physicians, and until May 22 for FDA-registered outsourcing facilities

The basis is the pooled data from the two pivotal approval trials, SURMOUNT-1 and SURMOUNT-2

In addition to demonstrating KL1s activity in THP-1-derived human macrophages and primary human neutrophils, we further examined whether macrophages derived from human peripheral blood mononuclear cells (PBMCs) could recapitulate the response