法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年8月26日•1 分钟阅读
FDA Grants ANDA077797 Approval for Cycbenzaprine Hydrochloride Tablets
The FDA approved ANDA077797 for prescription oral tablets of Cycbenzaprine Hydrochloride, 5 mg and 10 mg, manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.
法规动态
2026年8月26日•1 分钟阅读
FDA Approves Diprosone Topical Lotion (NDA 017781)
The FDA approved Diprosone lotion, a topical betamethasone dipropionate product (0.05% base) under NDA 017781. It is listed as discontinued but not withdrawn for safety reasons.
法规动态
2026年8月26日•1 分钟阅读
FDA Approves ANDA078395 for Dorzolamide Hydrochloride Ophthalmic Solution
The FDA has approved ANDA078395 for a 2% Dorzolamide Hydrochloride ophthalmic solution marketed by Advagen Pharma Ltd., with Rubicon Research as sponsor.
法规动态
2026年8月26日•1 分钟阅读
FDA Approves ANDA078101 for Teva’s Levetiracetam Oral Tablets
The FDA has approved labeling submissions for Teva Pharm’s discontinued levetiracetam tablets (250 mg, 500 mg, 750 mg, 1 g) under ANDA078101.
法规动态
2026年8月26日•1 分钟阅读
Fierce Pharma Introduces H2 2026 Regulatory Tracker for In‑Market Products
Fierce Pharma’s H2 2026 Regulatory Tracker logs progress of existing products, noting geographic expansions and new indications, even when updates aren’t full stories.
法规动态
2026年8月26日•1 分钟阅读
Sanofi’s Genzyme Ireland unit receives FDA Form 483, faces further reprimand
FDA inspectors issued a Form 483 to Sanofi’s Genzyme Ireland after a 2026 site visit, prompting additional regulatory reprimand.
法规动态
2026年8月26日•1 分钟阅读
Draeger alerts users to hose cracks in VentStar Resus Neo and Resuscitaire devices
Draeger reports observed hose cracks in VentStar Resus Neo and Resuscitaire; no confirmed patient harm yet.
法规动态
2026年8月26日•1 分钟阅读
Health Canada recalls Twins Herbal liquids Idakole and Pelorie for undeclared sildenafil
Health Canada has issued a recall of Twins Herbal’s Idakole and Pelorie liquid products, which were sold without market authorization and contain the undeclared prescription drug sildenafil. Consumers should stop use and contact a healthcare provider.
法规动态
2026年8月26日•1 分钟阅读
Draeger Alerts Potential Hose Cracks in VentStar Resus Neo and Resuscitaire Devices
Draeger reports users have found visible hose cracks in VentStar® Resus Neo and Resuscitaire devices before use; no health impacts reported but risk cannot be excluded.
法规动态
2026年8月26日•1 分钟阅读
South Korea Revises Drug Reimbursement Criteria, Opens Public Comment
The Ministry of Health and Welfare released draft amendments to coverage rules for antiepileptic, dry‑eye, autoimmune and respiratory drugs, effective July 1, with comments accepted until the 22nd.
法规动态
2026年8月26日•1 分钟阅读
South Korean Government Initiates Wide‑Scale Probe into Illegal Medical Practices Targeting Cancer Patients
The Ministry of Health and Welfare’s Abnormal and Fake Treatment Investigation Unit announced on the 18th that it will immediately begin on‑site investigations of suspected illegal practices such as patient recruitment, pay‑back schemes, and high‑cost non‑covered treatments aimed at cancer patients.
法规动态
2026年8月26日•1 分钟阅读
FDA Lists ANDA085199 for Discontinued Phendimetrazine Tartrate Oral Tablet
FDA’s database shows ANDA085199 for a discontinued 35 mg oral tablet of Phendimetrazine Tartrate submitted by PVT FORM.