February 1, 2018 / 3:10 PM / 22 days ago

BRIEF-Intercept Announces Updated U.S. Prescribing Information For Ocaliva

Feb 1 (Reuters) - Intercept Pharmaceuticals Inc:

* INTERCEPT ANNOUNCES UPDATED U.S. PRESCRIBING INFORMATION FOR OCALIVA® (OBETICHOLIC ACID) TO REINFORCE APPROPRIATE DOSING IN PBC PATIENTS WITH ADVANCED CIRRHOSIS

* INTERCEPT PHARMACEUTICALS INC - OCALIVA LABEL HAS BEEN REVISED TO INCLUDE A BOXED WARNING

* INTERCEPT PHARMACEUTICALS INC - INTERCEPT WILL BE DISSEMINATING UPDATED PRESCRIBING INFORMATION AND A MEDICATION GUIDE FOR PATIENTS

* INTERCEPT PHARMACEUTICALS INC - OCALIVA LABEL HAS BEEN REVISED TO INCLUDE A DOSING TABLE THAT REINFORCE EXISTING DOSING SCHEDULE FOR CERTAIN PATIENTS

* INTERCEPT PHARMACEUTICALS INC - U.S. FOOD AND DRUG ADMINISTRATION HAS ISSUED AN UPDATED DRUG SAFETY COMMUNICATION TO ACCOMPANY LABEL

* INTERCEPT PHARMACEUTICALS INC - UPDATED LABEL REINFORCES POSITIVE BENEFIT-RISK PROFILE OF OCALIVA WHEN USED AS DIRECTED

* INTERCEPT PHARMACEUTICALS - TABLE IS INCLUDED IN UPDATED PRESCRIBING INFORMATION TO INCREASE PROMINENCE OF RECOMMENDED OCALIVA DOSAGE BY DISEASE STAGE

* INTERCEPT PHARMA - TABLE INCLUDED UPDATED PRESCRIBING INFORMATION TO INCREASE PROMINENCE OF RECOMMENDED OCALIVA DOSAGE BY CHILD-PUGH CLASSIFICATION

* INTERCEPT PHARMACEUTICALS - ALSO WORKING WITH EMA TO UPDATE OCALIVA EUROPEAN SMPC TO REINFORCE APPROPRIATE DOSING IN PATIENTS WITH ADVANCED CIRRHOSIS

* INTERCEPT - CO‘S RECENT ASSESSMENT OF POSTMARKETING DATA DID NOT ESTABLISH CAUSAL RELATIONSHIP BETWEEN OCALIVA&LIVER DECOMPENSATION &/LIVER FAILURE Source text for Eikon: Further company coverage:

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