法规动态
2026年9月27日•1 分钟阅读
South Korea's Health Ministry to Form Permanent Unit to Combat Fake Medical Billing
The Ministry of Health and Welfare announced plans to create a dedicated permanent organization to tackle abnormal fake medical treatments, including fee paybacks and advance high‑cost payments.
法规动态
2026年9月27日•1 分钟阅读
Sanofi-Aventis Canada Recalls Certain Insulin Pens and Cartridges Over Freezing Risk
Sanofi-Aventis Canada is recalling 1,043 insulin pens and cartridges from ~80 Canadian sites after they may have been frozen during shipping, potentially reducing effectiveness.
法规动态
2026年9月25日•1 分钟阅读
Limited Number of Sarclisa Single-Use Vials Recalled in Nova Scotia Due to Possible Freezing
Health Canada recalls nine Sarclisa single-use vials from three Nova Scotia locations after possible freezing during shipment.
法规动态
2026年9月25日•1 分钟阅读
FDA Discontinues FOLEX Injectable Methotrexate Products (ANDA087695)
The FDA's ANDA087695 filing for FOLEX injectable methotrexate (25 mg, 50 mg, 100 mg) shows all three products are listed as discontinued.
法规动态
2026年9月24日•1 分钟阅读
FDA Grants ANDA209932 Approval for Magnesium Sulfate Injection (Pharmobedient)
Pharmobedient received FDA approval (ANDA209932) for its magnesium sulfate 5% injection in a plastic container, designated as a prescription product.
法规动态
2026年9月24日•1 分钟阅读
FDA Approves ANDA091667 for MISOPROSTOL Oral Tablets (Discontinued)
The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.
法规动态
2026年9月23日•1 分钟阅读
FDA Approves Sandoz Generic Trifluoperazine Hydrochloride Tablet (ANDA085785)
The FDA has approved ANDA085785 for Sandoz’s oral tablet of trifluoperazine hydrochloride, a prescription drug, with multiple manufacturing and labeling approvals spanning 1982‑1999.
法规动态
2026年9月23日•1 分钟阅读
FDA Approves ANDA 084872 for Meclizine Hydrochloride 25 mg Tablet (BUNDY)
The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.
法规动态
2026年9月23日•1 分钟阅读
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
法规动态
2026年9月20日•1 分钟阅读
South Korea Approves 44th Domestic New Drug, Latica Eye Drops 5%
MFDS approves Latica Eye Drops 5% for adult dry‑eye patients, marking Korea’s 44th domestically developed new drug and expanding treatment options.
法规动态
2026年9月20日•1 分钟阅读
Ajou Pharmaceutical’s Latica Eye Drops 5% Receives Approval as Korea’s 44th Domestic New Drug
Ajou Pharmaceutical, together with G.L. PharmTech, secured MFDS approval for Latica Eye Drops 5% (recopolabone hydrate, code AJU‑S56), marking the company’s first marketed new drug and Korea’s 44th domestically developed new drug for dry eye.
法规动态
2026年9月18日•1 分钟阅读
MFDS Announces Personnel Transfers and Promotions
The Ministry of Food and Drug Safety announced several staff transfers and promotions on Sep 4 and Sep 7, 2026, covering food safety, consumer protection and bio‑pharmaceutical divisions.