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FDA Daily

FDA daily for Tuesday, August 11, 2026

191 FDA records across 4 sections. 3 touch MedGrid's categories and are listed first.

191FDA Records
4 of 7Sections With Data
3Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Mon, Aug 10 (yesterday)
4
  • Glyburide Tablet

    Diabeta, Tablet, 5 mg (NDC 0093-9364-10) — Sanofi-Aventis U.S. LLC

    New · To Be Discontinued · Endocrinology/Metabolism

  • Glyburide Tablet

    Diabeta, Tablet, 2.5 mg (NDC 0093-9433-01) — Sanofi-Aventis U.S. LLC

    New · To Be Discontinued · Endocrinology/Metabolism

  • Glyburide Tablet

    Diabeta, Tablet, 1.25 mg (NDC 0093-9477-53) — Sanofi-Aventis U.S. LLC

    New · To Be Discontinued · Endocrinology/Metabolism

  • Glyburide Tablet

    Diabeta, Tablet, 5 mg (NDC 0093-9364-01) — Sanofi-Aventis U.S. LLC

    New · To Be Discontinued · Endocrinology/Metabolism

Drug approvalsCovers FDA's Tue, Aug 4 (a week ago)
13
  • DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

    DOXORUBICIN HYDROCHLORIDE — ALEMBIC

    ANDA219199 · Labeling

  • DOXORUBICIN HYDROCHLORIDE

    DOXORUBICIN HYDROCHLORIDE — QILU PHARM HAINAN

    ANDA219881 · Labeling

  • FENOFIBRATE

    FENOFIBRATE — BOSTAL

    ANDA208476 · Manufacturing (CMC)

  • ORENITRAM

    TREPROSTINIL DIOLAMINE — UNITED THERAP

    NDA203496 · Manufacturing (CMC)

  • FOUNDAYO

    ORFORGLIPRON CALCIUM — ELI LILLY AND CO

    NDA220934 · Labeling

  • DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

    DOXORUBICIN HYDROCHLORIDE — ZYDUS LIFESCIENCES

    ANDA212299 · Labeling

  • SACUBITRIL AND VALSARTAN

    SACUBITRIL, VALSARTAN — UMEDICA

    ANDA219946 · Original approval

  • NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

    NICARDIPINE HYDROCHLORIDE — FRESENIUS KABI USA

    ANDA219334 · Original approval

  • NEULASTA

    PEGFILGRASTIM — AMGEN

    BLA125031 · Labeling

  • DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

    DOXORUBICIN HYDROCHLORIDE — SUN PHARM

    ANDA203263 · Labeling

  • SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

    METFORMIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDE — MYLAN

    ANDA205981 · Labeling

  • ADEMPAS

    RIOCIGUAT — BAYER HLTHCARE

    NDA204819 · REMS

Showing 12 of 13. Search the rest in openFDA.

Drug recallsCovers FDA's Tue, Aug 4 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Tue, Aug 4 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Tue, Aug 4 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Tue, Jul 28 (two weeks ago)
11
  • ELISIO™-HX

    Nipro Medical Corporation

    K261399 · Substantially Equivalent · Gastroenterology, Urology

  • BodyTom Elite (NL4000)

    NeuroLogica Corp., a Samsung Company

    K253450 · Substantially Equivalent · Radiology

  • Revi System

    Bluewind Medical , Ltd.

    K253651 · Substantially Equivalent · Gastroenterology, Urology

  • Xpert Ankle

    Newclip Technics

    K261511 · Substantially Equivalent · Orthopedic

  • Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgic…

    Hartalega NGC Sdn. Bhd.

    K260558 · Substantially Equivalent · General, Plastic Surgery

  • Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)

    Datex-Ohmeda, Inc.

    K260326 · Substantially Equivalent · General Hospital

  • See-Mode Augmented Reporting Tool, Breast (SMART-B)

    See-Mode Technologies Pty, Ltd.

    K260303 · Substantially Equivalent · Radiology

  • CaRi-Heart

    Caristo Diagnostics , Ltd.

    DEN250042 · Unknown · Cardiovascular

  • V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/…

    Samsung Medison Co., Ltd.

    K261412 · Substantially Equivalent · Radiology

  • uMI Panvivo (uMI Panvivo M)

    Shanghai United Imaging Healthcare Co., Ltd.

    K261427 · Substantially Equivalent · Radiology

  • TruLift Expandable System

    Life Spine, Inc.

    K261430 · Substantially Equivalent · Orthopedic

Label changesCovers FDA's Tue, Jul 28 (two weeks ago)
3 touch MedGrid163
  • LidoPro Patch (Lidocaine 4%, Menthol 1%)Touches MedGrid categories

    Clinic Pharma

    Label version 2

  • Xylocaine MPFTouches MedGrid categories

    Sportpharm LLC

    Label version 1

  • LIDOCAINETouches MedGrid categories

    Patterson Dental

    Label version 6

  • SUGAMMADEX SODIUM

    STERISCIENCE SPECIALTIES PRIVATE LIMITED

    Label version 2

  • Drug label

    Label version 3

  • Drug label

    Label version 2

  • Mupirocin

    Preferred Pharmaceuticals Inc.

    Label version 3

  • Enalapril Maleate

    Golden State Medical Supply, Inc.

    Label version 2

  • Alprazolam

    Clinical Solutions Wholesale, LLC

    Label version 1

  • Atropine Sulfate

    Henry Schein, Inc.

    Label version 2

  • Dalfampridine

    Golden State Medical Supply, Inc.

    Label version 2

  • Drug label

    Label version 26

Showing 12 of 163. Search the rest in openFDA.

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.