FDA daily for Monday, March 3, 2025
In this issue: 20 approvals, 1 device recall and 70 label changes. 2 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.
- TRETINOIN
BARR LABS INC · TRETINOIN
- Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen
OCTINOXATE, OXYBENZONE, OCTISALATE · The Avon Company · TOPICAL
Drug and biologic approvals
FDA date:On Mon, Feb 24 FDA approved 6 new applications (1 brand or biologic, 5 generic) and 14 supplements to existing ones.
- MIUDELLA
SEBELA WOMENS HLTH · COPPER
- THIAMINE HYDROCHLORIDE
GLAND · THIAMINE HYDROCHLORIDE
- LOFEXIDINE HYDROCHLORIDE
MSN · LOFEXIDINE HYDROCHLORIDE
- INDOMETHACIN
AMNEAL · INDOMETHACIN
- BREXPIPRAZOLE
APOTEX · BREXPIPRAZOLE
- POSACONAZOLE
MSN · POSACONAZOLE
- TRETINOIN
BARR LABS INC · TRETINOIN
Device recalls
FDA date:FDA posted 1 device recall from 1 firm on Mon, Feb 24.
- BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the conti…
CareFusion 303, Inc. · Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue pot…
Label updates
FDA date:70 drug labels took effect on Mon, Feb 17; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen
OCTINOXATE, OXYBENZONE, OCTISALATE · The Avon Company · TOPICAL
- DESVENLAFAXINE
DESVENLAFAXINE · NuCare Pharmaceuticals,Inc. · ORAL
- Estradiol Vaginal
ESTRADIOL · NuCare Pharmaceuticals, Inc. · VAGINAL
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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