Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 076802 for Glimepiride Tablets (Discontinued)
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.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA077991 for OTC Cetirizine/Pseudoephedrine Extended‑Release Tablet
The FDA has approved ANDA077991 for an over‑the‑counter oral tablet containing 5 mg cetirizine hydrochloride and 120 mg pseudoephedrine hydrochloride, submitted by PLD Acquisitions.
Regulatory Updates
Sep 4, 2026•1 min read
GSK's Depemokimab Fails Korean Orphan‑Drug Review Over Efficacy Concerns
GSK's depemokimab for severe eosinophilic asthma was denied orphan‑drug status in Korea due to insufficient efficacy or safety advantage over existing biologics.
Regulatory Updates
Sep 4, 2026•1 min read
Boston Scientific Initiates Recall of Imager II Angiographic Catheters Over Tip Issue
Boston Scientific is recalling Imager II Angiographic Catheters after discovering reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.
Regulatory Updates
Sep 4, 2026•1 min read
Boston Scientific Initiates Recall of Imager II Angiographic Catheters
Boston Scientific is recalling Imager II catheters due to reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.
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Regulatory Updates
Sep 4, 2026•1 min read
Dongguk Pharmaceutical's Rosutanmet Tablets Lose Health Insurance Coverage After Approval Cancellation
Two Dongguk Pharmaceutical Rosutanmet tablet products (500/5 mg and 500/10 mg) will have health‑insurance reimbursement stopped from the 28th after the Daejeon regional authority cancelled their approvals.
Regulatory Updates
Sep 4, 2026•1 min read
Daewoong Bio receives 1‑month manufacturing suspension over claim handling lapse
Daewoong Bio was ordered by South Korea’s MFDS to halt production of its 300 mg Icosapent Ethyl soft capsules for one month after failing to process a consumer claim per its own standards.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution
The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Prilosec (Omeprazole) NDA 019810 Submissions
FDA approved several manufacturing and labeling submissions for Prilosec (omeprazole) products under NDA 019810, including priority reviews for 10 mg, 20 mg and 40 mg strengths.
Regulatory Updates
Sep 2, 2026•1 min read
Lawmaker Cho Bo-yoon Holds Forum on Monitoring Disability Convenience Facilities
Lawmaker Cho Bo-yoon convened over 100 officials and experts to discuss systematic maintenance of disability convenience facilities in Korea.
Regulatory Updates
Sep 2, 2026•1 min read
Olympus Issues Recall of BiCOAG Hemostasis Probe Over Adhesive Defect
Olympus advises immediate discontinuation of BiCOAG Hemostasis Probe due to potential ceramic tip detachment.
Regulatory Updates
Sep 1, 2026•1 min read
KPA Issues Alternative Drug List After DiOctahedral Mesylate Pediatric Indication Removed
Following the MFDS removal of the >24‑month pediatric indication for dioctahedral mesylate, the Korean Pharmaceutical Association provided a list of 32 OTC and 15 prescription alternatives for member pharmacies.