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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SALIVA safely and effectively. See full prescribing information for
SALIVA.
SALIVA (obeticholic
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What is fda adds boxed warning?
The FDA adds boxed warnings to drug labels to highlight serious or life-threatening risks associated with the medication.
Who is required to file fda adds boxed warning?
Manufacturers of prescription drugs and biologics are required to file FDA adds boxed warnings when new safety information is identified.
How to fill out fda adds boxed warning?
To fill out an FDA adds boxed warning, manufacturers must clearly state the mentioned risks, provide appropriate context, and follow formatting guidelines set by the FDA.
What is the purpose of fda adds boxed warning?
The purpose of an FDA adds boxed warning is to inform healthcare providers and patients about serious risks associated with a drug, encouraging safer usage.
What information must be reported on fda adds boxed warning?
Information must include the drug's name, the specific risks, action to be taken, and any relevant studies supporting the warning.
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