FDA daily for Monday, May 27, 2024
In this issue: 9 approvals, 13 device decisions and 64 label changes. 3 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.
- Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Sri Trang Gloves (Thailand) Public Company Limited · General Hospital
Drug and biologic approvals
FDA date:On Mon, May 20 FDA approved 4 new applications (2 brand or biologic, 2 generic) and 5 supplements to existing ones.
- TRAZODONE HYDROCHLORIDE
CROSSMEDIKA SA · TRAZODONE HYDROCHLORIDE
- YESAFILI
BIOCON BIOLOGICS INC · AFLIBERCEPT-JBVF
- OPUVIZ
SAMSUNG BIOEPIS CO LTD · AFLIBERCEPT-YSZY
- QUETIAPINE FUMARATE
IPCA LABS LTD · QUETIAPINE FUMARATE
Device clearances and approvals
FDA date:FDA decided 8 510(k)s and 5 PMA decisions on Mon, May 13.
- Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Sri Trang Gloves (Thailand) Public Company Limited · General Hospital
- Disposable Double Lumen Endobronchial Tube
Shenzhen Insighters Medical Technology Co., Ltd. · Anesthesiology
- MIM Monte Carlo Dosimetry
Mim Software, Inc. · Radiology
- BEAR 2 Body
Foreo, Inc. · Neurology
- REMEX-GR100
Remedi Co., Ltd. · Dental
- Brainomix 360 e-Lung
Brainomix Limited · Radiology
- Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
Healgen Scientific,, LLC · Clinical Toxicology
- 1060nm laser body slimming machine
Hebei JT Medical Co., Ltd. · General, Plastic Surgery
Label updates
FDA date:64 drug labels took effect on Mon, May 13; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Levofloxacin
LEVOFLOXACIN · Asclemed USA, Inc. · ORAL
FDA did not answer for Drug recalls, Food and supplement recalls, Drug shortages, 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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