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Regulatory Status Summary (as of July 29, 2026) Category 2 restricted status: Removed (April 2026) FDA approval: None USP/NF monograph: None 503A Bulks List: PCAC recommended inclusion (July 2324, 2026, nonbinding)
S., & McCann, S
Radlinger, B
Clinical observations show that constipation peaks during the first 48 weeks of therapy and typically resolves in many patients without intervention as tolerance develops
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