규제 업데이트

Korean Pharmaceutical Association secured a three‑day temporary reimbursement for di‑octahedral smectite dispensed to patients under 19, easing pharmacy billing concerns after pediatric indication was withdrawn.

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.

The FDA approved ANDA084231 for a 500 mg methocarbamol tablet submitted by Puracap Pharm; the product is currently listed as discontinued.

Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.

The FDA approved application ANDA076576 for oral Sotalol Hydrochloride tablets (80 mg, 120 mg, 160 mg) from Sun Pharm Industries; all listed products are marked discontinued.

The FDA approved ANDA083606 for an oral tablet of butabarital sodium (16.2 mg) submitted by Solvay; the product is listed as discontinued.

FDA NDA017406 for DICOPAC KIT, sponsored by GE Healthcare, indicates the product is discontinued and lists its submission history and active ingredients.

FDA has approved Cipla Ltd.'s ANDA077318 for two oral cetirizine hydrochloride allergy tablets (5 mg and 10 mg), both listed as discontinued.

South Korea's Minimum Wage Committee approved a 3.68% increase, setting the 2027 hourly minimum wage at 17,000 KRW.

The UK Medicines and Healthcare products Regulatory Agency listed several field safety notices for devices such as femoral head adapters, infusion pump cassettes and fluoroscopic X‑ray systems between 24‑28 August 2026.

FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.

The FDA approved ECONOPRED, a 0.125% prednisolone acetate ophthalmic suspension, under NDA 017468 with multiple manufacturing submissions and a 2003 labeling approval. The product is now listed as discontinued.