相关临床试验
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药物批准
555
批准总数
监管机构
1
监管机构数
成立时间
2003
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- The FDA classified a nationwide recall of levothyroxine sodium tablets as Class II on July 17 after routine stability testing found the tablets were subpotent, meaning they contain less active drug than labeled. - The recall, initiated by manufacturer Lupin Pharmaceuticals and distributed by Major Pharmaceuticals and Cardinal Health, covers seven strengths (25–150 mcg) across 12 products with expiration dates extending to January 2027. - Patients are advised to continue taking their medication, as stopping a recalled drug can cause more harm than continuing, and pharmacies are not required to notify patients directly. - Experts note the recall demonstrates the system working as intended, with routine monitoring and blood tests allowing clinicians to detect low thyroid function before significant adverse effects occur.
- The FDA has classified a voluntary recall of over 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1% as Class II, the second-highest risk level. - Lupin Limited initiated the recall on June 4 after a single market complaint from distributor Hilco Vision reported foreign particulate matter in the product. - The foreign substance could potentially cause inflammatory responses, mechanical irritation, corneal injury, and secondary ocular inflammation, according to a Health Hazard Assessment. - Affected bottles span 5 mL, 10 mL, and 15 mL sizes with expiration dates ranging from July 2026 through March 2028, and patients are advised to consult their prescribing physician before discontinuing use.
• A recent study reveals that ezetimibe monotherapy increases serum coproporphyrin I (CPI) concentrations in healthy individuals, potentially affecting OATP1B1 function. • Co-administration of ezetimibe and rifampin further elevates CPI levels, complicating the assessment of drug interactions in patients undergoing combination therapies. • The research supports CPI as a reliable biomarker for monitoring OATP1B1 activity, crucial for personalized medicine approaches and reducing adverse drug reactions. • Ezetimibe-glucuronide, a metabolite of ezetimibe, significantly reduces cellular CPI accumulation, suggesting a broader role in modulating transporter function beyond cholesterol reduction.
