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Treats bile acid synthesis disorders due to single enzyme defects (SEDs). NDA 205750, held by Mirum. Cholic Acid.
As of Nov 15, 2026, NDA 205750 (Cholbam), held by Mirum, was first approved by FDA on Mar 17, 2015, with 2 approved supplements and 0 published complete response letters.
First approved: Mar 17, 2015
Review: Priority
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
CHOLBAM is a bile acid indicated for:
Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs).
Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat-soluble vitamin absorption. Limitations of use: The safety and effectiveness of CHOLBAM on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs including Zellweger spectrum disorders have not been established.. 1.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
