FDA daily

FDA daily for Tuesday, September 15, 2026

In this issue: 3 approvals and 14 device decisions. 1 item touches categories MedGrid carries, and it comes 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 Tue, Sep 8 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 1 supplement to existing ones.

  • BRIVARACETAM

    ZHEJIANG JUTAI PHARM · BRIVARACETAM

    ANDA220136Generic (ANDA)Prescription
  • IBRUTINIB

    HETERO LABS LTD V · IBRUTINIB

    ANDA211182Generic (ANDA)Prescription
Browse drug and biologic approvals in FDA data →

Device clearances and approvals

FDA date:

FDA decided 10 510(k)s and 4 PMA decisions on Tue, Sep 1.

Browse device clearances and approvals in FDA data →

FDA did not answer for Food and supplement recalls, Device recalls, Drug recalls, Labels, Drug shortages 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.