Isotretinoin manufacturers have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for isotretinoin.
This is the second drug to receive a labeling update under the agency s Project Renewal program, which aims to keep labels of older cancer drugs up to date with current practice.
Alcohol abstinence was achieved by nearly two thirds of patients with alcohol use disorder (AUD) and cirrhosis after taking naltrexone, with minimal adverse events.