FDA daily

FDA daily for Friday, May 31, 2024

In this issue: 12 approvals, 15 device recalls, 17 device decisions and 60 label changes. 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 Fri, May 24 FDA approved 3 new applications (1 brand or biologic, 2 generic) and 9 supplements to existing ones.

  • LACOSAMIDE

    MACLEODS PHARMS · LACOSAMIDE

    ANDA208466Generic (ANDA)Prescription
  • ERLOTINIB HYDROCHLORIDE

    HETERO LABS LTD V · ERLOTINIB HYDROCHLORIDE

    ANDA209267Generic (ANDA)Prescription
  • ONYDA XR

    TRIS PHARMA INC · CLONIDINE HYDROCHLORIDE

    NDA217645Drug (NDA)Prescription
Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 15 device recalls from 8 firms on Fri, May 24.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 13 510(k)s and 4 PMA decisions on Fri, May 17.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

60 drug labels took effect on Fri, May 17; 5 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 →

FDA did not answer for Drug shortages, Food and supplement recalls, Drug recalls while this issue was written; those sections will fill in on a later visit.

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.