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FDA Daily

FDA daily for Thursday, August 13, 2026

135 FDA records across 3 sections. 5 touch MedGrid's categories and are listed first.

135FDA Records
3 of 7Sections With Data
5Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Wed, Aug 12 (yesterday)
Nothing from FDA for this date
Drug approvalsCovers FDA's Thu, Aug 6 (a week ago)
7
  • LEVETIRACETAM

    LEVETIRACETAM — BAXTER HLTHCARE CORP

    ANDA208458 · Original approval

  • INPEFA

    SOTAGLIFLOZIN — LEXICON PHARMS INC

    NDA216203 · Labeling

  • XOLAIR

    OMALIZUMAB — GENENTECH

    BLA103976 · Labeling

  • METFORMIN HYDROCHLORIDE

    METFORMIN HYDROCHLORIDE — WATSON LABS INC

    ANDA076818 · Labeling

  • TRYVIO

    APROCITENTAN — IDORSIA

    NDA217686 · Labeling

  • PRAVASTATIN SODIUM

    PRAVASTATIN SODIUM — PHARMAZONE

    ANDA077491 · Manufacturing (CMC)

  • LORATADINE AND PSEUDOEPHEDRINE SULFATE

    LORATADINE, PSEUDOEPHEDRINE SULFATE — DR REDDYS

    ANDA220448 · Original approval

Drug recallsCovers FDA's Thu, Aug 6 (a week ago)
Nothing from FDA for this date
Food and supplement recallsCovers FDA's Thu, Aug 6 (a week ago)
Nothing from FDA for this date
Device recallsCovers FDA's Thu, Aug 6 (a week ago)
Nothing from FDA for this date
Device clearancesCovers FDA's Thu, Jul 30 (two weeks ago)
16
  • TnR Cranial Implant

    T&R BIOFAB CO., Ltd.

    K251959 · Substantially Equivalent · Neurology

  • Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

    Suite 201, National Innovation Centre

    K261410 · Substantially Equivalent · Neurology

  • AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

    Stryker Endoscopy

    K262369 · Substantially Equivalent · Orthopedic

  • LOGIQ Focus

    GE Medical Systems Ultrasound and Primary Care Diagnostics

    K261835 · Substantially Equivalent · Radiology

  • PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

    Salter Labs

    K261389 · Substantially Equivalent · Anesthesiology

  • dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 1…

    Philips Medical Systems Nederland B.V.

    K262330 · Substantially Equivalent · Radiology

  • SMARTVERTIGO™ Vestibular Assessment System

    VertigoDx, Inc.

    K260566 · Substantially Equivalent · Neurology

  • neXus Ultrasonic Surgical Aspirator System

    Misonix, LLC

    K261448 · Substantially Equivalent · Unknown

  • Obsidian® Press Over Zirconia

    Prismatik Dentalcraft, Inc.

    K262239 · Substantially Equivalent · Dental

  • SeptAlign (SPLN001)

    Spirair, Inc.

    K260620 · Substantially Equivalent · Ear, Nose, Throat

  • Motivista (CT-155)

    Click Therapeutics, Inc.

    K254038 · Substantially Equivalent · Neurology

  • SmartGuide Disposable Guides and Grids

    UC-CARE , Ltd.

    K260161 · Substantially Equivalent · Radiology

Showing 12 of 16. Search the rest in openFDA.

Label changesCovers FDA's Thu, Jul 30 (two weeks ago)
5 touch MedGrid112
  • Aspercreme with Lidocaine DryTouches MedGrid categories

    Chattem, Inc.

    Label version 6

  • OzempicTouches MedGrid categories

    A-S Medication Solutions

    Label version 1

  • DROSPIRENONE AND ETHINYL ESTRADIOLTouches MedGrid categories

    Redpharm Drug

    Label version 1

  • ACOLYE Lidocaine Cream Topical Analgesia CreamTouches MedGrid categories

    Guangdong Aimu Biological Technology Co., Ltd

    Label version 1

  • LidocaineTouches MedGrid categories

    Benco Dental

    Label version 5

  • Muscle Ice

    Peaceful Mountain, Inc.

    Label version 5

  • GABAPENTIN

    TIME CAP LABORATORIES, INC

    Label version 11

  • Elitek

    Sanofi-Aventis U.S. LLC

    Label version 25

  • Cetirizine Hydrochloride

    Cardinal Health 107, LLC

    Label version 15

  • Drug label

    Label version 11

  • Pancreaforce

    BioActive Nutritional, Inc.

    Label version 2

  • Hypertonic Saline

    NAVEH PHARMA (1996) LTD

    Label version 3

Showing 12 of 112. 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.

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.