FDA daily for Saturday, August 15, 2026
In this issue: 1 shortage update and 39 label changes.
Drug shortages
FDA date:FDA updated 1 shortage entry on Fri, Aug 14: 1 new, 1 to be discontinued.
- Fulvestrant Injection
Fresenius Kabi USA, LLC
Label updates
FDA date:39 drug labels took effect on Sat, Aug 1. Below: those, and labels carrying a boxed warning.
- Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS · Proficient Rx LP · ORAL
- Amiodarone Hydrochloride
AMIODARONE HYDROCHLORIDE · Redpharm Drug · 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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