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FDA's safety page lists them under bulk drug substances nominated but withdrawn. The new briefing packet also marks the cited nominations as withdrawn, but says FDA elected to present the substances to PCAC anyway.[1][3] So three statements that sound similar mean different things: Removed from Category 2 does not mean placed in Category 1

The benzyl alcohol preservative inhibits microbial growth, allowing multi-dose vials to remain stable for up to 28 days once opened

A review published in Cureus (2024) noted that while TB-500 shows promise for soft tissue regeneration, additional research is necessary before clinical translation can occur

For adult off-label use, typical daily doses often range from 0.2 mg (200 mcg) to 0.5 mg (500 mcg)