규제 업데이트

The FDA database shows ANDA076458 for fluoxetine hydrochloride oral solution, marketed under the brand Fluoxetine, with a discontinued status and multiple labeling submissions.

The FDA database lists two discontinued oral tablet products named AMINOPHYLLIN (100 mg and 200 mg) and documents multiple labeling and manufacturing submissions approved between 1977 and 1991.

Balt Extrusion is voluntarily recalling certain ANRYV connector lots after bacterial endotoxin test failures; no patient harm reported.

Balt Extrusion is voluntarily recalling specific ANRYV connector lots after non‑conforming bacterial endotoxin test results, affecting standalone connectors and those in selected kits; no patient harm reported.

The MFDS will host a public‑private meeting on the 15th in Seoul to discuss regulatory and review processes for digital convergence medicines under the Digital Medical Device Act.

Drug prevention education in Korea improves risk awareness and confidence to refuse, with youth perception scores climbing from 64.5 to 83.8 between 2024 and 2025.

President Lee Jae‑myung urged ministries to swiftly approve and integrate abortion drugs into a public safety framework, with lawmakers pressing parliament for rapid action.

The Ministry of Health and Welfare has asked police to investigate 12 additional medical institutions suspected of providing fee refunds ('payback') to cancer patients, raising the total to 18 cases.

FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.

CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.

Cipla Limited’s generic efavirenz 600 mg tablet has been granted tentative approval by the FDA under ANDA 077916.

The FDA has approved ANDA209610 for a prescription topical gel combining clindamycin phosphate (EQ 1.2% base) and benzoyl peroxide (3.75%). The product is marketed by Padagis Israel Pharmaceuticals Ltd.