FDA daily for Saturday, February 22, 2025
In this issue: 2 approvals, 1 device decision and 15 label changes. 1 item touches categories MedGrid carries, and it comes 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.
- PROBIOTIC RICE Sunscreen
PROBIOTIC RICE SUNSCREEN · GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd · CUTANEOUS
Drug and biologic approvals
FDA date:On Sat, Feb 15 FDA approved no new applications and 2 supplements to existing ones.
- SERTRALINE HYDROCHLORIDE
ASCENT PHARMS INC · SERTRALINE HYDROCHLORIDE
- NAPROXEN
HIKMA · NAPROXEN
Device clearances and approvals
FDA date:FDA decided 0 510(k)s and 1 PMA decision on Sat, Feb 8.
Browse device clearances and approvals in FDA data →Label updates
FDA date:15 drug labels took effect on Sat, Feb 8; 1 is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- PROBIOTIC RICE Sunscreen
PROBIOTIC RICE SUNSCREEN · GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd · CUTANEOUS
- Diclofenac Sodium
DICLOFENAC SODIUM · Asclemed USA, Inc. · TOPICAL
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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