Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Lists ANDA076458 for Fluoxetine Hydrochloride Oral Solution (Discontinued)
The FDA database shows ANDA076458 for fluoxetine hydrochloride oral solution, marketed under the brand Fluoxetine, with a discontinued status and multiple labeling submissions.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Records Show Discontinued AMINOPHYLLIN Tablet Products and Historical 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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
Balt Extrusion Recalls ANRYV Connectors Over Endotoxin Test Issue
Balt Extrusion is voluntarily recalling certain ANRYV connector lots after bacterial endotoxin test failures; no patient harm reported.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
Balt Extrusion Voluntarily Recalls ANRYV Connectors Over Bacterial Endotoxin Test Failure
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
MFDS to Hold Public-Private Forum on Digital Convergence Medicines Regulation
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
Korean Government Boosts Drug Prevention Education, Youth Awareness Scores Rise
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
President Lee Calls for Rapid Approval and Prescription System for Abortion Medication
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
South Korea adds 12 hospitals to police investigation over alleged cancer patient fee refunds
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Approves ANDA078511 for Midazolam Hydrochloride Injection
FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
CARACO Receives Tentative FDA Approval for Escitalopram (ANDA078219)
CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
Cipla Efavirenz 600mg Tablet Gets FDA Tentative Approval (ANDA 077916)
Cipla Limited’s generic efavirenz 600 mg tablet has been granted tentative approval by the FDA under ANDA 077916.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Approves ANDA209610 for Clindamycin Phosphate and Benzoyl Peroxide Gel
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.