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US FDA Eliminating 'Sub-Indications' From Inflammatory Bowel Disease Labels

Executive Summary

Claims such as induction of clinical remission will now be placed in the clinical studies section for new IBD approvals.

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Pfizer's Xeljanz Approval In UC Includes Postmarket Study On Long-Term Effects

JAK inhibitor, now first oral UC medication in US, is approved for both 5mg and 10mg, but label currently discourages 10mg after 16 weeks.

User Fee Goal Dates

Estimated FDA review deadlines for pending applications. Updated weekly.

Aubagio Approval Reflects FDA’s Evolving View On Multiple Sclerosis Drugs

Sanofi’s teriflunomide is indicated broadly for treating relapsing forms of MS. The claim marks a departure from previously approved MS drugs, in which the specific effects seen in clinical trials are described in the Indications section. FDA said the Aubagio claim more closely reflects how physicians actually use the drugs and represents a more flexible regulatory approach that enabled approval of a second, lower dose.


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