FDA daily

FDA daily for Tuesday, February 25, 2025

In this issue: 20 approvals, 20 device decisions and 128 label changes.

Drug and biologic approvals

FDA date:

On Tue, Feb 18 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 18 supplements to existing ones.

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Device clearances and approvals

FDA date:

FDA decided 13 510(k)s and 7 PMA decisions on Tue, Feb 11.

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Label updates

FDA date:

128 drug labels took effect on Tue, Feb 11. Below: those, and labels carrying a boxed warning.

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How the FDA daily is written

Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.