FDA daily for Saturday, February 3, 2024
In this issue: 2 approvals, 4 device decisions and 5 label changes.
Drug and biologic approvals
FDA date:On Sat, Jan 27 FDA approved no new applications and 2 supplements to existing ones.
- PERINDOPRIL ERBUMINE
HIKMA · PERINDOPRIL ERBUMINE
- PACLITAXEL
ACTAVIS TOTOWA · PACLITAXEL
Device clearances and approvals
FDA date:FDA decided 1 510(k) and 3 PMA decisions on Sat, Jan 20.
- RESPONSE Rib and Pelvic System
OrthoPediatrics Corp. · Orthopedic
Label updates
FDA date:5 drug labels took effect on Sat, Jan 20. Below: those, and labels carrying a boxed warning.
- Cisplatin
CISPLATIN · Sagent Pharmaceuticals · INTRAVENOUS
- Paclitaxel
PACLITAXEL · Sagent Pharmaceuticals · INTRAVENOUS
- CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUM · Aurolife Pharma 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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