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AOD-9604 Regulatory Status As of June 2026, AOD-9604 is not FDA-approved for any therapeutic use

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Size:1000 mcg/ml - 10 ml (Pack of 1)

It does not appear on the bulks list at 21 CFR 216.23(a), it is no longer in any category of FDA’s interim compounding policy because the nominator withdrew the nomination, and FDA continues to publish the safety concern it identified, stating that it “has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.” Unauthorized is not the same as prohibited: AOD 9604 is not among the finished drug products withdrawn from the market at 21 CFR 216.24, so the accurate description is unauthorized rather than banned, and unauthorized is not a green light either