Regulatorische Updates

Samjin Pharmaceutical held employee dementia‑awareness training and is seeking the Ministry‑backed ‘Dementia Overcoming Leading Company’ certification.

The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.

The FDA lists the FLUONID ointment (0.025% fluocinonide) under ANDA 087157 as discontinued, sponsored by Allergan Herbert.

The FDA has marked the oral tablet product Dextroamphetamine Sulfate (5 mg) from sponsor MAST MM as discontinued under ANDA 086521.

The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.

The FDA approved ANDA 077395 for an oral suspension of Paroxetine Hydrochloride; the product is listed as discontinued and has a series of labeling supplement approvals.

Korea's MFDS adds new safety precautions to a beclomethasone‑formoterol‑glycopyrrolate inhaler and revises caspofungin labeling regarding CRRT‑related drug adsorption.

A recent KPA News piece notes that pharmacies sometimes dispense medication after misreading a patient’s name on prescriptions, echoing a lyric from miss A’s song.

FDA records show labeling approvals for discontinued quinapril/hydrochlorothiazide tablets across multiple supplemental applications from 2011 to 2022.

FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.

Debate continues on whether to discuss further regulatory improvements for telemedicine‑based medication delivery before the system is launched, highlighting the need for legislative action.

The FDA has approved a series of labeling submissions for three discontinued oral fenofibrate tablet products (54 mg, 107 mg, 160 mg) under ANDA 076520, with approvals spanning 2005‑2021.