FDA daily for Friday, November 13, 2026
In this issue: 1 shortage update, 9 approvals, 41 device decisions and 136 label changes. 2 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
- Liraglutide
LIRAGLUTIDE · Lupin Pharmaceuticals, Inc. · SUBCUTANEOUS
Drug shortages
FDA date:FDA updated 1 shortage entry on Thu, Nov 12: 1 status update.
- Azacitidine Injection
Dr. Reddy's Laboratories, Inc. · Available
Drug and biologic approvals
FDA date:On Fri, Nov 6 FDA approved 5 new applications (0 brand or biologic, 5 generic) and 4 supplements to existing ones.
- TAFAMIDIS MEGLUMINE
AUROBINDO PHARMA LTD · TAFAMIDIS MEGLUMINE
- VENLAFAXINE HYDROCHLORIDE
YICHANG HUMANWELL · VENLAFAXINE HYDROCHLORIDE
- BRIVARACETAM
APPCO · BRIVARACETAM
- BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
MICRO LABS · BRIMONIDINE TARTRATE, TIMOLOL MALEATE
- TOFACITINIB CITRATE
SCIEGEN PHARMS · TOFACITINIB CITRATE
Device clearances and approvals
FDA date:FDA decided 25 510(k)s and 16 PMA decisions on Fri, Oct 30.
- RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit (66802253)
Smith & Nephew Medical, Ltd. · General, Plastic Surgery
- PolySense
Itamar Medical , Ltd. · Neurology
- eplex RP3 Control M530; eplex RP3 Negative
Maine Molecular Quality Controls, Inc. · Microbiology
- Arctic Sun Neonatal ArcticGel Pad
Medivance, Inc. · Cardiovascular
- B`orze Inc Laser Family (Sorren/Adonis)
Borze, Inc. · General, Plastic Surgery
- Zirconia Collective 4Y Dental Zirconia Blank
Zirconia Collective, Inc. · Dental
- DS Core Detect
Dentsply Sirona, Inc. · Radiology
- Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
Changsha Sinocare, Inc. · Clinical Chemistry
- VIVO (9002)
Catheter Precision, Inc. · Cardiovascular
- EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Ever Fortune.Ai, Co., Ltd. · Radiology
- ULSPIRA TS Nitric Oxide Therapy System
Airgas Therapeutics, LLC · Anesthesiology
- Shining3D Clear Aligner System
Hangzhou SHINING3D Dental Technology Co., Ltd. · Dental
- Xpert® Hemorrhagic Fever Panel
Cepheid · Immunology
- cobas eplex respiratory pathogen panel 3
GenMark Diagnostics, Inc. · Microbiology
- AngioVac F1885
AngioDynamics, Inc. · Cardiovascular
Label updates
FDA date:136 drug labels took effect on Fri, Oct 30; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Liraglutide
LIRAGLUTIDE · Lupin Pharmaceuticals, Inc. · SUBCUTANEOUS
- Lorazepam
LORAZEPAM · PD-Rx Pharmaceuticals, Inc. · ORAL
- Tenofovir Disoproxil Fumarate
TENOFOVIR DISOPROXIL FUMARATE · PD-Rx Pharmaceuticals, Inc. · ORAL
- Celecoxib
CELECOXIB · Unichem Pharmaceuticals (USA), Inc. · ORAL
- FUROSEMIDE
FUROSEMIDE · Henry Schein, Inc. · INTRAMUSCULAR, INTRAVENOUS
- ADZYNMA
APADAMTASE ALFA · TAKEDA PHARMACEUTICALS AMERICA, INC.
FDA did not answer for Food and supplement recalls, Drug recalls, Device recalls while this issue was written; those sections will fill in on a later visit.
How the FDA daily is written
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 and 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. Complete response letters appear the day after FDA publishes a batch.
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