FDA Daily

FDA daily for Friday, August 7, 2026

202 FDA records across 4 sections. 10 touch MedGrid's categories and are listed first.

202FDA Records

4 of 7Sections With Data

10Touch MedGrid Categories

Drug shortagesCovers FDA's Thu, Aug 6 (yesterday)

Rifapentine Tablet, Film Coated
Priftin, Tablet, Film Coated, 150 mg (NDC 0088-2102-24) — Sanofi-Aventis U.S. LLC
Revised · Resolved · Anti-Infective
Isocarboxazid Tablet
Marplan, Tablet, 10 mg, 100 count bottle (NDC 72336-032-01) — Lifsa Drugs LLC
Revised · Current · Psychiatry

Drug approvalsCovers FDA's Fri, Jul 31 (a week ago)

1 touch MedGrid17

KEYTRUDA QLEXTouches MedGrid categories
PEMBROLIZUMAB, BERAHYALURONIDASE ALFA-PMPH — MERCK SHARP DOHME
BLA761467 · Labeling
THIAMINE HYDROCHLORIDE
THIAMINE HYDROCHLORIDE — MANKIND PHARMA
ANDA220513 · Original approval
ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM — ALKEM LABS LTD
ANDA206465 · Labeling
EPINEPHRINE
EPINEPHRINE — DEVA HLDING
ANDA217426 · Original approval
PIROXICAM
PIROXICAM — MICRO LABS
ANDA206152 · Labeling
ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM — MANKIND PHARMA
ANDA206603 · Labeling
PLUVICTO
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN — NOVARTIS
NDA215833 · Efficacy
ZIMRIXBY
RITUXIMAB-CDXX — DR REDDYS LABS SA
BLA761376 · Original approval
LYNOZYFIC
LINVOSELTAMAB-GCPT — RENGENERON PHARMACEUTICALS, INC.
BLA761400 · REMS
ATROPINE SULFATE
ATROPINE SULFATE — GLAND
ANDA219996 · Original approval
DOCOSANOL
DOCOSANOL — KLM LABS PVT
ANDA220017 · Original approval
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE — AJANTA PHARMA LTD
ANDA211012 · Labeling

Showing 12 of 17. Search the rest in openFDA.

Drug recallsCovers FDA's Fri, Jul 31 (a week ago)

Nothing from FDA for this date

Food and supplement recallsCovers FDA's Fri, Jul 31 (a week ago)

Nothing from FDA for this date

Device recallsCovers FDA's Fri, Jul 31 (a week ago)

Nothing from FDA for this date

Device clearancesCovers FDA's Fri, Jul 24 (two weeks ago)

1 touch MedGrid31

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Ac…Touches MedGrid categories
Olympus Surgical Technologies America
K261221 · Substantially Equivalent · General, Plastic Surgery
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
MANTIZ Co., Ltd.
K260362 · Substantially Equivalent · Orthopedic
FARADRIVE Steerable Sheath (M004PF21M402)
Boston Scientific Corporation
K262165 · Substantially Equivalent · Cardiovascular
Accuro 3S
Rivanna Medical, Inc.
K253452 · Substantially Equivalent · Radiology
TMINI Miniature Robotic System
THINK Surgical, Inc.
K261024 · Substantially Equivalent · Neurology
Careflux H60;Careflux H70;Careflux V500
Fresenius Medical Care Renal Therapies Group, LLC
K261267 · Substantially Equivalent · Gastroenterology, Urology
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
Ge Medical Systems Information Technologies, Inc.
K253277 · Substantially Equivalent · Cardiovascular
Temporary Keratoprosthesis (QuickSet TKP)
Eyekon Medical, Inc.
K261312 · Substantially Equivalent · Ophthalmic
VS-370CF, VS-370CT
VISION MEDICAL Co., Ltd.
K262152 · Substantially Equivalent · Gastroenterology, Urology
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avella…
Hycor Biomedical
K261027 · Substantially Equivalent · Immunology
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
Thermo Fisher Scientific (Oxoid Ltd.)
K261781 · Substantially Equivalent · Microbiology
5 Wavelength LED Facemask (TN2508)
iSMART Developments, Ltd.
K260598 · Substantially Equivalent · General, Plastic Surgery

Showing 12 of 31. Search the rest in openFDA.

Label changesCovers FDA's Fri, Jul 24 (two weeks ago)

8 touch MedGrid152

Lidocaine Plus Pain RelievingTouches MedGrid categories
CVS Pharmacy
Label version 2
SERYNTH HEMORRHOIDTouches MedGrid categories
Jiangxi Yudexi Pharmaceutical Co., LTD
Label version 2
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDTouches MedGrid categories
Jiangxi Yudexi Pharmaceutical Co., LTD
Label version 2
Zytherial Lidocaine 4% Pain Relief PatchTouches MedGrid categories
Wenzhou Yuyuan Pharmaceutical Co., Ltd.
Label version 3
FOLKI COSMETIC Psoriasis CreamTouches MedGrid categories
Wenzhou Yuyuan Pharmaceutical Co., Ltd.
Label version 1
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitTouches MedGrid categories
Xact Packing Limited
Label version 2
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40Touches MedGrid categories
ESTEE LAUDER INC
Label version 1
Arlun Lidocaine CreamTouches MedGrid categories
Guangzhou Jingliang Cosmetics Co., Ltd.
Label version 1
Metoclopramide
American Health Packaging
Label version 5
Metaxalone
Preferred Pharmaceuticals Inc.
Label version 1
Drug label
Label version 4
Potassium Chloride Extended-Release
Upsher-Smith Laboratories, LLC
Label version 8

Showing 12 of 152. 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.

FDA daily for Friday, August 7, 2026

Sections in This Issue