FDA daily for Tuesday, September 1, 2026
In this issue: 9 approvals and 122 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.
Drug and biologic approvals
FDA date:On Tue, Aug 25 FDA approved no new applications and 9 supplements to existing ones.
- TADALAFIL
SUN PHARM · TADALAFIL
- TIVICAY
VIIV HLTHCARE · DOLUTEGRAVIR SODIUM
- TIVICAY PD
VIIV HLTHCARE · DOLUTEGRAVIR SODIUM
- GABAPENTIN
RUBICON RESEARCH · GABAPENTIN
- ISOPROTERENOL HYDROCHLORIDE
EUGIA PHARMA · ISOPROTERENOL HYDROCHLORIDE
- ZIIHERA
JAZZ PHARMS · ZANIDATAMAB-HRII
Label updates
FDA date:122 drug labels took effect on Tue, Aug 18; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Minoxidil
MINOXIDIL · Keranique · TOPICAL
- atomoxetine
ATOMOXETINE · Glenmark Pharmaceuticals Inc., USA · ORAL
- METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE · Granules Pharmaceuticals Inc. · ORAL
- Tindazole
TINIDAZOLE · REMEDYREPACK INC. · ORAL
- Glyburide and Metformin Hydrochloride
GLYBURIDE AND METFORMIN HYDROCHLORIDE · Bryant Ranch Prepack · ORAL
FDA did not answer for Device recalls, Food and supplement recalls, Drug shortages, Clearances, 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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