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FDA Daily

FDA daily for Thursday, August 27, 2026

156 FDA records across 3 sections. 2 touch MedGrid's categories and are listed first.

156FDA Records
3 of 7Sections With Data
2Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Wed, Aug 26 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Thu, Aug 20 (a week ago)
11
  • COTELLIC

    COBIMETINIB FUMARATE — GENENTECH INC

    NDA206192 · Labeling

  • LISINOPRIL

    LISINOPRIL — ANNORA PHARMA

    ANDA218419 · Original approval

  • ZELBORAF

    VEMURAFENIB — HOFFMANN LA ROCHE

    NDA202429 · Labeling

  • EMPAVELI

    PEGCETACOPLAN — APELLIS PHARMS

    NDA215014 · Efficacy

  • TICAGRELOR

    TICAGRELOR — PHARMOBEDIENT

    ANDA218869 · Original approval

  • JORNAY PM

    METHYLPHENIDATE HYDROCHLORIDE — IRONSHORE PHARMS

    NDA209311 · Manufacturing (CMC)

  • DEXMETHYLPHENIDATE HYDROCHLORIDE

    DEXMETHYLPHENIDATE HYDROCHLORIDE — ASCENT PHARMS INC

    ANDA215523 · Labeling

  • TAKHZYRO

    LANADELUMAB-FLYO — DYAX CORP.

    BLA761090 · Labeling

  • OGSIVEO

    NIROGACESTAT HYDROBROMIDE — SPRINGWORKS

    NDA217677 · Labeling

  • YESAFILI

    AFLIBERCEPT-JBVF — BIOCON BIOLOGICS INC

    BLA761274 · Labeling

  • ASCORBIC ACID

    ASCORBIC ACID — ZYDUS PHARMS

    ANDA220873 · Original approval

Drug recallsCovers FDA's Thu, Aug 20 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Thu, Aug 20 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Thu, Aug 20 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Thu, Aug 13 (two weeks ago)
14
  • Any-Cem

    Mediclus Co., Ltd.

    K254201 · Substantially Equivalent · Dental

  • BP Go (BPP-855)

    Wellvii, Inc.

    K261061 · Substantially Equivalent · Cardiovascular

  • MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

    Mikron Makina San. ve Tic. Ltd. Sti.

    K260277 · Substantially Equivalent · Orthopedic

  • MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution

    Menicon Co, Ltd.

    K253795 · Substantially Equivalent · Ophthalmic

  • Levo Gen 2 Tinnitus Therapy System

    Levo Medical Corporation

    K260413 · Substantially Equivalent · Ear, Nose, Throat

  • AIR Recon DL

    GE Medical Systems

    K253808 · Substantially Equivalent · Radiology

  • BIS™ Advance pEEG Module

    Covidien LP

    K260907 · Substantially Equivalent · Neurology

  • TrachFlush

    Aw Technologies Aps

    K261499 · Substantially Equivalent · Anesthesiology

  • CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set

    CERENOVUS, Inc.

    K262398 · Substantially Equivalent · Cardiovascular

  • Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-62…

    Joytech Healthcare Co. , Ltd.

    K253425 · Substantially Equivalent · Cardiovascular

  • Dashboard (P007000)

    Hill-Rom, Inc.

    K260211 · Substantially Equivalent · Cardiovascular

  • VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)

    Freyja Healthcare, LLC

    K261139 · Substantially Equivalent · Gastroenterology, Urology

Showing 12 of 14. Search the rest in openFDA.

Label changesCovers FDA's Thu, Aug 13 (two weeks ago)
2 touch MedGrid131
  • XylocaineTouches MedGrid categories

    Dentsply Pharmaceutical

    Label version 10

  • ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENTouches MedGrid categories

    ISNTREE Inc.

    Label version 1

  • Childrens Allergy Relief

    CVS Pharmacy

    Label version 4

  • ofloxacin

    Lifestar Pharma LLC

    Label version 6

  • Lamotrigine

    Amneal Pharmaceuticals LLC

    Label version 20

  • FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SCENT

    Amber Glow Cosmetics Limited

    Label version 1

  • levocetirizine dihydrochloride

    Golden State Medical Supply, Inc.

    Label version 3

  • SprinJene

    Health and Natural Beauty USA Corp

    Label version 2

  • Drug label

    Label version 2

  • allergy relief childrens

    CVS Pharmacy

    Label version 6

  • Daytime Cold and Flu

    Amazon.com Services LLC

    Label version 3

  • nighttime severe cold and flu

    Amazon.com Services LLC

    Label version 2

Showing 12 of 131. 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.