FDA daily for Tuesday, July 8, 2025
In this issue: 28 approvals, 13 device decisions and 78 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.
- OPDIVO
BRISTOL MYERS SQUIBB · NIVOLUMAB
- Walgreens SPF 50 Premium Moisturizing Continuous Sunscreen
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · WALGREEN COMPANY · TOPICAL
- Finasteride
FINASTERIDE · Atlantic Biologicals Corps · ORAL
Drug and biologic approvals
FDA date:On Tue, Jul 1 FDA approved 1 new application (0 brand or biologic, 1 generic) and 27 supplements to existing ones.
- DOXYCYCLINE HYCLATE
DR REDDYS · DOXYCYCLINE HYCLATE
- OPDIVO
BRISTOL MYERS SQUIBB · NIVOLUMAB
Device clearances and approvals
FDA date:FDA decided 7 510(k)s and 6 PMA decisions on Tue, Jun 24.
- GPS Advanced; GPS Advanced Cannula
Prosidyan, Inc. · General Hospital
- PediFlex Flexible Nail System
OrthoPediatrics Corp. · Orthopedic
- Bridge Plus Occlusion Balloon (590-002)
Philips Image Guided Therapy Devices · Cardiovascular
- Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
Spectrum Medical S.R.L. · Cardiovascular
- HyperSnap Surgical System (HSS)
Hypervision Surgical · Gastroenterology, Urology
- MIST IC
Imagine Milling Technologies, LLC · Dental
- ProAM ALIF System
Pro Surgical, Inc. · Orthopedic
Label updates
FDA date:78 drug labels took effect on Tue, Jun 24; 4 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Walgreens SPF 50 Premium Moisturizing Continuous Sunscreen
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · WALGREEN COMPANY · TOPICAL
- Finasteride
FINASTERIDE · Atlantic Biologicals Corps · ORAL
- Shade SPF30 Climate Control
OCTISALATE, OCTOCRYLENE, ZINC OXIDE · Micro Current Technology, Inc. · TOPICAL
- Blooskim BEEF TALLOW SUNSCREEN
NON-NANO ZINC OXIDE · Guangzhou Haishi Biological Technology Co., Ltd. · TOPICAL
- Etodolac
ETODOLAC · NORTHSTAR RX LLC · ORAL
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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