Drugs and Medicinal Substances

Actigall

Alimentary Tract and Metabolism Agents

Ursodeoxycholic acid, also known as ursodiol and abbreviated UDCA, is a secondary bile acid produced in humans and most other animal species through metabolism of primary bile acids by intestinal bacteria. It was first identified in the bile of bears and takes its name from the genus Ursus. In purified pharmaceutical form it is used to treat and prevent a range of liver and bile duct diseases, working through several mechanisms: it reduces the cholesterol saturation of bile, which can dissolve certain gallstones, and it also has immunomodulating and anti-inflammatory effects on the epithelial cells lining the gastrointestinal and biliary tracts. Ursodeoxycholic acid, in an application filed by Allergan, was approved for use in the United States in December 1987 and was granted orphan drug status; it is now available as a generic medication under numerous brand names including Actigall, Urso, Ursofalk and Ursosan. It is a prescription-only medicine in major markets including the United States, United Kingdom, Canada and Australia, and its chemical formula is C24H40O4.

Facts
Drug Class
Gallstone dissolution agents 4
Mechanism of Action
Decreases the production of cholesterol and dissolves the cholesterol in bile to prevent stone formation 4
Approved Use
Dissolving gallstones in people who do not want or cannot have gallbladder surgery 4
First Approved / Isolated Year
1987 5
Classification
Approval Status
Approved 1
ATC ClassSourced to the subject's own account
A: Alimentary Tract and Metabolism 2
Route of Administration
Oral 3
Sources
1. EMBL-EBI ChEMBL: ChEMBL molecule record CHEMBL1551 (ursodiol)
EMBL-EBI ChEMBLfirst_approval
Quote, first_approval
"first_approval": 1987
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code A
Quote, First-level anatomical group codes, Code A
Alimentary tract and metabolism
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3. Ursodeoxycholic acid (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
By mouth
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4. Ursodiol: MedlinePlus Drug Information
  • Why is this medication prescribed, classification sentence
    Ursodiol is in a class of medications called gallstone dissolution agents.
  • Why is this medication prescribed, first sentence
    Ursodiol is used to dissolve gallstones in people who do not want surgery or cannot have surgery to remove gallstones.
  • Why is this medication prescribed, mechanism sentence
    It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation
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5. Federal Register: Determination That ACTIGALL (Ursodiol) Was Not Withdrawn for Safety Reasons
NDA 019594 approval history
Quote, NDA 019594 approval history
ACTIGALL (Ursodiol) Capsule, 150 Milligrams, was initially approved by the FDA on December 31, 1987
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Ursodeoxycholic acid (Wikipedia)
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