Regulatory Updates
Sep 17, 2026•1 min read
Online Mall Sells Three OTC Drugs Despite Recent Pharmacy Act Fine, Raising Safety Concerns
Three OTC medicines were found listed for sale on an online shop, even after a recent fine for illegal online dispensing, highlighting gaps in drug safety oversight.
Regulatory Updates
Sep 17, 2026•1 min read
Eun-gyosan OTC Drug Listed for Cold‑Related Sore Throat, Thirst, Cough and Headache in Korea
A pharmacist’s case note highlights that Korea’s Eun-gyosan OTC product is officially indicated for throat pain, thirst, cough and headache accompanying the common cold.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sandoz Children’s Cetirizine Hydrochloride Chewable Tablets (ANDA 078692)
The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.
Regulatory Updates
Sep 15, 2026•1 min read
Pharmacists in Jeonbuk Join 351-Day Protest Over Han‑Yak OTC Sales
Jeonbuk pharmacists gathered outside the presidential office, urging the government and parliament to resolve the issue of traditional‑medicine pharmacists selling OTC drugs.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ZADITOR Ophthalmic OTC Solution (ANDA077200)
FDA has approved ZADITOR, an over‑the‑counter ophthalmic solution containing 0.025% ketotifen fumarate (application ANDA077200).
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Over-the-Counter Lansoprazole Tablet (NDA 208025)
The FDA granted approval for an OTC oral tablet of lansoprazole 15 mg under NDA 208025, listed under several brand names and marketed by multiple retailers.
Regulatory Updates
Sep 10, 2026•1 min read
Korean Health Insurance Drug List Shrinks, OTC Items Decline Faster Than Prescription
The number of drugs covered by Korea’s health insurance has fallen steadily, with over‑the‑counter medicines dropping 25.2% over five years—more sharply than prescription drugs.
Regulatory Updates
Sep 9, 2026•1 min read
JoA Pharmaceutical Reintroduces Gareo-Aq Digestive Medicine After 3-Year Clinical Reassessment
JoA Pharmaceutical has re‑launched its OTC digestive aid Gareo‑Aq, featuring DHBE, after completing a three‑year clinical re‑evaluation across six Korean medical centers.
Regulatory Updates
Sep 5, 2026•1 min read
Gyeonggi Pharmacy Leaders Oppose Government’s Home Delivery Expansion for Telemedicine
Gyeonggi regional pharmacy chairs reject the government’s plan to broaden home delivery of medicines and OTC items, citing conflict with the Constitutional Court ruling.
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 3, 2026•1 min read
Korean Pharmacist Group Calls for Further Revisions to OTC Standard Manufacturing Criteria
The Korean Ministry of Food and Drug Safety announced a partial amendment to OTC drug manufacturing standards; a pharmacist association praised the move but urged broader, realistic updates.
Regulatory Updates
Sep 3, 2026•1 min read
KPA reports 283 OTC adverse events, highlighting risks with common cold medicines
Analysis of 283 OTC adverse cases reported over three months shows cold medicines, oral antihistamines and decongestants most frequently involved.