FDA daily

FDA daily for Friday, March 14, 2025

In this issue: 21 approvals, 7 device recalls, 33 device decisions and 109 label changes. 2 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, Mar 7 FDA approved 3 new applications (1 brand or biologic, 2 generic) and 18 supplements to existing ones.

  • OMLYCLO

    CELLTRION INC · OMALIZUMAB-IGEC

    BLA761399Biologic (BLA)Prescription
  • ARFORMOTEROL TARTRATE

    MICRO LABS · ARFORMOTEROL TARTRATE

    ANDA218555Generic (ANDA)Prescription
  • KETOCONAZOLE

    ZYDUS LIFESCIENCES · KETOCONAZOLE

    ANDA218559Generic (ANDA)Prescription
Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 7 device recalls from 1 firm on Fri, Mar 7.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 20 510(k)s and 13 PMA decisions on Fri, Feb 28.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

109 drug labels took effect on Fri, Feb 28; 2 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 →

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.