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Ocaliva Approval History

FDA Approved: Yes (First approved May 27, 2016)
Brand name: Ocaliva
Generic name: obeticholic acid
Dosage form: Tablets
Company: Intercept Pharmaceuticals, Inc.
Treatment for: Primary Biliary Cholangitis

Ocaliva (obeticholic acid) is a first-in-class farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis.

Development History and FDA Approval Process for Ocaliva

DateArticle
May 27, 2016Approval FDA Grants Accelerated Approval to Ocaliva (obeticholic acid) for Primary Biliary Cholangitis
Apr 10, 2016FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of Primary Biliary Cirrhosis
Dec 17, 2015FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC
Aug 31, 2015FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
Jun 29, 2015Intercept Pharmaceuticals Submits NDA for Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis
May 19, 2015Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH
Mar 31, 2011Intercept Pharmaceuticals Announces Positive Phase II Results for Obeticholic Acid (INT-747) as Monotherapy in Primary Biliary Cirrhosis

Further information

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