FDA daily for Sunday, July 26, 2026
In this issue: 1 approval and 12 label changes.
Drug and biologic approvals
FDA date:On Sun, Jul 19 FDA approved 1 new application (1 brand or biologic, 0 generic) and no supplements to existing ones.
- AIR
NOBLE GAS SOLUTIONS INC. · AIR
Label updates
FDA date:12 drug labels took effect on Sun, Jul 12. Below: those, and labels carrying a boxed warning.
- Morphine Sulfate
MORPHINE SULFATE · Hikma Pharmaceuticals USA Inc. · INTRAVENOUS
- DICLOFENAC SODIUM
DICLOFENAC SODIUM · HAWAII REPACK, INC · TOPICAL
FDA did not answer for Device recalls, Drug recalls, Drug shortages, Food and supplement recalls, Clearances 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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