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In July 2016, FDA published a notice in the Federal Register announcing the availability of the proposed PDUFA VI Commitment Letter, as well as a public meeting to discuss the proposed recommendations for the PDUFA VI reauthorization

Continued Focus: Continue to monitor for any new or persistent side effects and communicate them to our team

Strategic dietary modifications can significantly reduce the severity and frequency of these symptoms

The critical period for potential fetal effects is first trimester organogenesis, making early discontinuation important

However, if itching is severe, persistent beyond 4872 hours, or accompanied by spreading rash, significant swelling, or signs of infection, contact your GP or healthcare provider for assessment