FDA daily for Tuesday, May 28, 2024
In this issue: 10 approvals, 1 device recall, 15 device decisions and 70 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.
- Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash
ZINC OXIDE · Babo Botanicals, Inc. · TOPICAL
Drug and biologic approvals
FDA date:On Tue, May 21 FDA approved 5 new applications (0 brand or biologic, 5 generic) and 5 supplements to existing ones.
- ALBUTEROL SULFATE
ARMSTRONG PHARMS · ALBUTEROL SULFATE
- SUCRALFATE
STRIDES PHARMA · SUCRALFATE
- CYCLOSPORINE
DEVA HOLDING AS · CYCLOSPORINE
- LANREOTIDE ACETATE
INVAGEN PHARMS · LANREOTIDE ACETATE
- THEOPHYLLINE
ZYDUS LIFESCIENCES · THEOPHYLLINE
Device recalls
FDA date:FDA posted 1 device recall from 1 firm on Tue, May 21.
- Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
OptumHealth Care Solutions LLC · Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including bat…
Device clearances and approvals
FDA date:FDA decided 3 510(k)s and 12 PMA decisions on Tue, May 14.
- BNLE Hydrophilic Jacketed Peripheral Guidewire
Biomerics Nle · Cardiovascular
- Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
Aoj Health Technology Co., Ltd. · Obstetrics/Gynecology
- Aventus Clot Management System
Inquis Medical · Anesthesiology
Label updates
FDA date:70 drug labels took effect on Tue, May 14; 3 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash
ZINC OXIDE · Babo Botanicals, Inc. · TOPICAL
- Estradiol
ESTRADIOL · Amneal Pharmaceuticals NY LLC · TRANSDERMAL
- Fluoxetine
FLUOXETINE · Bryant Ranch Prepack · ORAL
- Jasmiel
DROSPIRENONE AND ETHINYL ESTRADIOL · Afaxys Pharma, LLC
FDA did not answer for Drug shortages, Food and supplement recalls, Drug 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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