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FDA Daily

FDA daily for Tuesday, October 13, 2026

23 FDA records across 3 sections.

23FDA Records
3 of 7Sections With Data
0Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Oct 12 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Tue, Oct 6 (a week ago)
8
  • RHAPSIDO

    REMIBRUTINIB — NOVARTIS

    NDA218436 · Efficacy

  • SODIUM BICARBONATE

    SODIUM BICARBONATE — BAXTER HLTHCARE CORP

    NDA218524 · Labeling

  • VALSARTAN

    VALSARTAN — AMNEAL PHARMS

    ANDA204011 · Labeling

  • SERTRALINE HYDROCHLORIDE

    SERTRALINE HYDROCHLORIDE — ALMATICA

    NDA215133 · Labeling

  • LISDEXAMFETAMINE DIMESYLATE

    LISDEXAMFETAMINE DIMESYLATE — APOTEX

    ANDA216944 · Labeling

  • SUGAMMADEX SODIUM

    SUGAMMADEX SODIUM — SHANDONG

    ANDA215701 · Original approval

  • SOLRIAMFETOL

    SOLRIAMFETOL — AUROBINDO PHARMA LTD

    ANDA218725 · Original approval

  • PROGLYCEM

    DIAZOXIDE — TEVA BRANDED PHARM

    NDA017453 · Labeling

Drug recallsCovers FDA's Tue, Oct 6 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Oct 6 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Oct 6 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Sep 29 (two weeks ago)
12
  • Fast Absorbing PGLA

    Riverpoint Medical, LLC

    K263073 · Substantially Equivalent · General, Plastic Surgery

  • THERMEO® I MSI

    Pro3Dure Medical GmbH

    K260031 · Substantially Equivalent · Unknown

  • Electric Wheelchair (0080)

    Xuzhou Heabens Medical Technology Co., Ltd.

    K262241 · Substantially Equivalent · Physical Medicine

  • NeckTune™ SA Cervical Cage

    Medyssey Co., Ltd.

    K262726 · Substantially Equivalent · Orthopedic

  • SmartRead(TM) Medical Device Identifier (4100)

    BridgeSource Medical Corporation

    DEN260007 · Unknown · Unknown

  • QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)

    QT Medical, Inc.

    K260250 · Substantially Equivalent · Cardiovascular

  • Power Mobility Scooter (MA03)

    Nanjing Mijo Technology Co., Ltd.

    K262213 · Substantially Equivalent · Physical Medicine

  • CAS-One IR

    Cascination AG

    K261225 · Substantially Equivalent · Radiology

  • Elucid FFR-IQ (B.1)

    Elucid Bioimaging, Inc.

    K262015 · Substantially Equivalent · Cardiovascular

  • Syngo Carbon Space (VA4)

    Siemens Healthineers AG

    K263048 · Substantially Equivalent · Radiology

  • MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)

    Zhejiang Kailang Technology Co., Ltd.

    K262553 · Substantially Equivalent · Physical Medicine

  • Spinalogic Bone Growth Stimulator

    Djo, LLC

    K262721 · Substantially Equivalent · Orthopedic

Label changesCovers FDA's Tue, Sep 29 (two weeks ago)
3
  • Clopidogrel

    Westminster Pharmaceuticals, LLC

    Label version 8

  • childrens allergy relief

    CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

    Label version 3

  • Temazepam

    Preferred Pharmaceuticals Inc.

    Label version 4

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.

Subscribe with any feed reader, or point an email tool at theRSS feed. For the rules behind the headlines, see Regulations Research.

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.