法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年9月25日•1 分钟阅读
FDA Approves ANDA077947 for Fluconazole Injectable Products (Discontinued)
The FDA has approved ANDA077947 submitted by Baxter Healthcare Corp for two discontinued Fluconazole injectable products in 0.9% sodium chloride, strengths 200 mg/100 mL and 400 mg/200 mL.
法规动态
2026年9月25日•1 分钟阅读
FDA ANDA077657: Lorazepam Tablet Discontinuations and Submission History
The FDA’s ANDA077657 for lorazepam tablets (0.5 mg, 1 mg, 2 mg) lists all products as discontinued and details several supplemental labeling submissions.
法规动态
2026年9月25日•1 分钟阅读
FDA Approves ANDA077060 for Metformin Hydrochloride Extended‑Release Tablet by Zydus Lifesciences
The FDA has granted approval for ANDA077060, authorizing the prescription extended‑release metformin hydrochloride tablet (500 mg) marketed by Zydus Lifesciences.
法规动态
2026年9月25日•1 分钟阅读
FDA Approves ANDA 076768 for Alendronate Sodium Tablets
The FDA has granted approval for an Abbreviated New Drug Application (ANDA) 076768 covering multiple strengths of alendronate sodium tablets, manufactured by Exelan Pharmaceuticals and Cipla USA.
法规动态
2026年9月25日•1 分钟阅读
FDA Approves Chartwell Allopurinol Generic (ANDA077353)
FDA has approved Chartwell RX's generic allopurinol tablets (100 mg and 300 mg) under ANDA 077353, confirming prescription status and labeling updates.
法规动态
2026年9月25日•1 分钟阅读
FDA Discontinues Furosemide Injectable (NDA018025) after Multiple Submissions
The FDA record for NDA018025 shows the injectable form of furosemide marked as discontinued after a series of approved labeling and manufacturing supplemental submissions.
法规动态
2026年9月25日•1 分钟阅读
Abbott Updates Amulet IFU to Highlight Pulmonary Artery Risk
Abbott has revised the instructions for use of its Amplatzer Amulet left atrial appendage occluder to specifically contraindicate placement near the pulmonary artery and added guidance on distance assessment.
法规动态
2026年9月25日•1 分钟阅读
Abbott Updates Amulet™ IFU to Highlight Pulmonary Artery Risk
Abbott revises the Amulet™ Left Atrial Appendage Occluder instructions to specify pulmonary artery as a contraindicated adjacent structure and adds guidance on device‑to‑artery distance.
法规动态
2026年9月25日•1 分钟阅读
Canada Recalls PERMA-HAND Silk Suture for Unapproved Tubing Fluid
Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.
法规动态
2026年9月25日•1 分钟阅读
Health Canada Recall: PERMA‑HAND™ Silk Suture Contaminated with Alcohol‑Based Tubing Fluid
Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.
法规动态
2026年9月25日•1 分钟阅读
FDA Approves ANDA 084031 for Sulfisozole 500 mg Oral Tablet (Discontinued)
The FDA granted approval (ANDA 084031) for BARR's sulfisozole 500 mg oral tablet, which is listed as discontinued. A labeling supplement was filed in 1995.
法规动态
2026年9月25日•1 分钟阅读
FDA Approves ANDA081030 for Quinidine Sulfate Tablet (Sun Pharm Industries)
Sun Pharm Industries' quinidine sulfate tablet (200 mg) received FDA approval under ANDA081030, with manufacturing and labeling submissions approved between 1989 and 2010. The product is currently listed as discontinued.