FDA daily for Monday, June 10, 2024
In this issue: 23 approvals, 4 device recalls, 1 device decision and 8 label changes.
Drug and biologic approvals
FDA date:On Mon, Jun 3 FDA approved 4 new applications (0 brand or biologic, 4 generic) and 19 supplements to existing ones.
- ATORVASTATIN CALCIUM
MACLEODS PHARMS · ATORVASTATIN CALCIUM
- METHOTREXATE SODIUM
ALEMBIC · METHOTREXATE SODIUM
- ARFORMOTEROL TARTRATE
DR REDDYS · ARFORMOTEROL TARTRATE
- TOFACITINIB CITRATE
AUROBINDO PHARMA LTD · TOFACITINIB CITRATE
Device recalls
FDA date:FDA posted 4 device recalls from 2 firms on Mon, Jun 3.
- Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
ARROW INTERNATIONAL Inc. · Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The…
- Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
ARROW INTERNATIONAL Inc. · Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The…
- Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
ARROW INTERNATIONAL Inc. · Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The…
- IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
Ion Beam Applications S.A. · Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Device clearances and approvals
FDA date:FDA decided 0 510(k)s and 1 PMA decision on Mon, May 27.
Browse device clearances and approvals in FDA data →Label updates
FDA date:8 drug labels took effect on Mon, May 27. Below: those, and labels carrying a boxed warning.
- Valproic Acid
VALPROIC ACID · NorthStar Rx 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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