FDA daily

FDA daily for Wednesday, May 22, 2024

In this issue: 12 approvals, 12 drug recalls, 9 device recalls, 25 device decisions, 107 label changes and 21 food or supplement recalls. 3 items touch categories MedGrid carries, and they come first.

For MedGrid's categories

Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.

Drug and biologic approvals

FDA date:

On Wed, May 15 FDA approved 1 new application (0 brand or biologic, 1 generic) and 11 supplements to existing ones.

  • LACOSAMIDE

    CHARTWELL RX · LACOSAMIDE

    ANDA215154Generic (ANDA)Prescription
Browse drug and biologic approvals in FDA data →

Drug recalls

FDA date:

FDA's enforcement report dated Wed, May 15 lists 12 drug recalls: 2 Class I, 9 Class II, 1 Class III.

Browse drug recalls in FDA data →

Device recalls

FDA date:

FDA posted 9 device recalls from 6 firms on Wed, May 15.

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Device clearances and approvals

FDA date:

FDA decided 7 510(k)s and 18 PMA decisions on Wed, May 8.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

107 drug labels took effect on Wed, May 8; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.

Browse label updates in FDA data →

Food and supplement recalls

FDA date:

FDA's enforcement report dated Wed, May 15 lists 21 food or supplement recalls: 8 Class I, 12 Class II, 1 Class III.

Browse food and supplement recalls in FDA data →

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.