US FDA References Off-Label Use In Otherwise Bland Labeling Draft Guidance
Product labels can be required to have warnings related to commonly prescribed unapproved uses with significant safety risks.
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Physician education on dosing also likely as firm hopes to show that serious adverse events in patients with less-advanced primary biliary cholangitis may not be related to the drug.
FDA's warning about 19 deaths related to excessive, off-label dosing for Ocaliva in primary biliary cholangitis spurs fears doctors will curtail prescribing and, worse, that the larger upcoming NASH market opportunity may be affected.
New labeling format will apply initially to recently approved drugs and products receiving approval for new uses, agency says.