規制動向

Despite focus on rare disease and oncology, Korea's drug price reform still limits innovative treatments for common chronic conditions, says Seoul National University economist.

The FDA approved NDA011960 for ARISTOCORT oral syrup, a 2 mg/5 mL Triamcinolone Acetate product by Astellas, now listed as discontinued.

The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.

Seoul Pharmaceutical Association delegates passed an urgent motion calling for the Korean Pharmaceutical Association to convene an interim general assembly to discuss the government's expansion of telemedicine prescription drug delivery.

The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.

The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.

The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).

The FDA has approved ANDA204213 for FYAVOLV, a prescription oral tablet combining norethindrone acetate and ethinyl estradiol, manufactured by Lupin Pharmaceuticals.

From Nov 27, Korea’s Ministry of Health and Welfare will regulate the ‘one pharmacist, one pharmacy’ principle for both opening and operating pharmacies, with penalties for operating multiple outlets.

The Seoul Pharmacists Association convened an interim delegate general meeting, adopted a resolution demanding government action on telemedicine, drug delivery, safety‑stock medicines, and warehouse pharmacies.

Jo Won‑jun raises concerns over proposals to amend a law on non‑face‑to‑face prescription drug delivery, citing lack of implementation and safety issues.

The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.