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1 Indications And Usage Ocaliva ® Is Indicated For The Treatment Of Primary Biliary Cholangitis (Pbc) In Combination With Ursodeoxycholic Acid (Udca) In Adults With An Inadequate Response To Udca, Or As Monotherapy In Adults Unable To Tolerate Udca. This Indication Is Approved Under Accelerated Approval Based On A Reduction In Alkaline Phosphatase (Alp) [See Clinical Studies (14) ] . An Improvement In Survival Or Disease-Related Symptoms Has Not Been Established. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. Ocaliva, A Farnesoid X Receptor (Fxr) Agonist, Is Indicated For The Treatment Of Primary Biliary Cholangitis (Pbc) In Combination With Ursodeoxycholic Acid (Udca) In Adults With An Inadequate Response To Udca, Or As Monotherapy In Adults Unable To Tolerate Udca. This Indication Is Approved Under Accelerated Approval Based On A Reduction In Alkaline Phosphatase (Alp). An Improvement In Survival Or Disease-Related Symptoms Has Not Been Established. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. ( 1 )
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