규제 업데이트

The FDA has approved ANDA 076251 submitted by Barr for fluoxetine hydrochloride oral capsules, 40 mg base, now listed as discontinued.

From Sept 1, insurance reimbursement prices for 68 drugs in South Korea will drop, with reductions ranging from under 1% to over 20%; pharmacies must manage inventory differences and physical returns.

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.

The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.

The Ministry of Health and Welfare will discuss expanding drug delivery to all telemedicine patients and forming a public‑private council to address pharmacist duties in a non‑face‑to‑face setting.

MediBioLab released GumGoods, a gum‑health functional food leveraging the MFDS‑approved PMEC propolis extract after eight years of research.

Anguk Pharmaceutical organized a company-wide compliance session, inviting lawyer Lee Jong-heon of Jipyung to discuss fair-trade and corporate governance risks across industries.

Democratic, Joo Kook Innovation and Progressive Party members of the National Assembly Health and Welfare Committee called on the People Power Party to stop its boycott, appoint committee leadership, and resume legislative work.

Detection of medicinal and narcotic substances in imported health foods rose from 281 cases in 2023 to 871 in 2025, a 3.1‑fold increase, raising consumer safety concerns.

The FDA authorized Celcuity's small‑molecule inhibitor Revtorpyk (gedatolisib) for hormone‑receptor‑positive, HER2‑negative breast cancer without PIK3CA mutations, to be used with fulvestrant and optionally Ibrance.

Novo Nordisk received European Commission approval for its oral Wegovy for obese or overweight adults, positioning it ahead of Eli Lilly’s pending oral GLP‑1 drug in Europe.

Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.