FDA daily

FDA daily for Friday, June 7, 2024

In this issue: 23 approvals, 12 device recalls, 28 device decisions and 121 label changes. 4 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 31 FDA approved no new applications and 23 supplements to existing ones.

  • NADOLOL

    INGENUS PHARMS LLC · NADOLOL

    ANDA210786Generic (ANDA)Discontinued
  • LISINOPRIL AND HYDROCHLOROTHIAZIDE

    INVAGEN PHARMS · HYDROCHLOROTHIAZIDE, LISINOPRIL

    ANDA204058Generic (ANDA)Prescription
  • ONDANSETRON

    SANDOZ · ONDANSETRON

    ANDA078050Generic (ANDA)Prescription
  • ZANAFLEX

    LEGACY · TIZANIDINE HYDROCHLORIDE

    NDA020397Drug (NDA)Discontinued
  • CLOBAZAM

    HETERO LABS LTD III · CLOBAZAM

    ANDA209796Generic (ANDA)Prescription
  • LAMOTRIGINE

    LUPIN LTD · LAMOTRIGINE

    ANDA078691Generic (ANDA)Discontinued
Browse drug and biologic approvals in FDA data →

Device recalls

FDA date:

FDA posted 12 device recalls from 7 firms on Fri, May 31.

Browse device recalls in FDA data →

Device clearances and approvals

FDA date:

FDA decided 19 510(k)s and 9 PMA decisions on Fri, May 24.

Browse device clearances and approvals in FDA data →

Label updates

FDA date:

121 drug labels took effect on Fri, May 24; 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 →

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.