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FDA Daily

FDA daily for Monday, September 28, 2026

22 FDA records across 3 sections.

22FDA Records
3 of 7Sections With Data
0Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Sun, Sep 27 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Mon, Sep 21 (a week ago)
11
  • DIVALPROEX SODIUM

    DIVALPROEX SODIUM — REDDYS

    ANDA090070 · Labeling

  • ACETAZOLAMIDE

    ACETAZOLAMIDE — INDICUS PHARMA

    ANDA090779 · Labeling

  • DIVALPROEX SODIUM

    DIVALPROEX SODIUM — DR REDDYS LABS LTD

    ANDA090161 · Labeling

  • PALONOSETRON HYDROCHLORIDE

    PALONOSETRON HYDROCHLORIDE — FRESENIUS KABI USA

    ANDA206801 · Labeling

  • PALONOSETRON HYDROCHLORIDE

    PALONOSETRON HYDROCHLORIDE — FRESENIUS KABI USA

    ANDA206802 · Labeling

  • EVEROLIMUS

    EVEROLIMUS — NOVITIUM PHARMA

    ANDA220597 · Original approval

  • VALACYCLOVIR HYDROCHLORIDE

    VALACYCLOVIR HYDROCHLORIDE — AUROBINDO PHARMA

    ANDA090682 · Labeling

  • NEVIRAPINE

    NEVIRAPINE — MACLEODS PHARMS

    ANDA090688 · Labeling

  • BRAVNETSA

    LUTETIUM LU-177 DOTATATE — LANTHEUS MEDICAL

    ANDA217060 · Original approval

  • DULOXETINE HYDROCHLORIDE

    DULOXETINE HYDROCHLORIDE — BRECKENRIDGE

    ANDA203088 · Manufacturing (CMC)

  • WINREVAIR

    SOTATERCEPT-CSRK — MERCK SHARP DOHME

    BLA761363 · Labeling

Drug recallsCovers FDA's Mon, Sep 21 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Mon, Sep 21 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Mon, Sep 21 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Mon, Sep 14 (two weeks ago)
8
  • colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

    Ovesco Endoscopy AG

    K253481 · Substantially Equivalent · Gastroenterology, Urology

  • Yumizen H550

    HORIBA ABX SAS

    K260781 · Substantially Equivalent · Hematology

  • Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

    Maduro Medical, Inc.

    K261089 · Substantially Equivalent · Cardiovascular

  • RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACT…

    Xenix Medical

    K262193 · Substantially Equivalent · Orthopedic

  • qCT Lung (v1.0)

    Qure.Ai Technologies Pvt. , Ltd.

    K261517 · Substantially Equivalent · Radiology

  • Hand-held Dental X-ray System (HyperLight-M)

    Changzhou Sifary Medical Technology Co., Ltd.

    K260795 · Substantially Equivalent · Dental

  • BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth

    Becton Dickinson and Company

    K262163 · Substantially Equivalent · Microbiology

  • HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)

    Eurosets S.R.L

    K261438 · Substantially Equivalent · Cardiovascular

Label changesCovers FDA's Mon, Sep 14 (two weeks ago)
3
  • captopril

    AMICI PHARMA, INC.

    Label version 4

  • CrystLCare Regeneration Plus

    GreenMark Biomedical Inc.

    Label version 1

  • Cephalexin

    PD-Rx Pharmaceuticals, Inc.

    Label version 37

How the FDA Daily Is WrittenSources, dates and what gets flagged

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 recalls, 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. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.

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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.