2000年以来FDA批准的新放射性药物
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表1. 2000年以来FDA批准的新放射性药物
| 序号 | 药品名称 | 活性成分 | 适应症 | 批准日期 | 申请机构 |
| 1 | NETSPOT | Gallium dotatate Ga-68 | A diagnostic imaging agent to detect rare neuroendocrine tumors | 2016-6-1 | AAA USA INC |
| 2 | Axumin | Fluciclovine F-18 | A new diagnostic imaging agent to detect recurrent prostate cancer | 2016-5-27 | BLUE EARTH |
| 3 | Neuraceq | Florbetaben F-18 | For Positron EmissionTomography (PET) imaging of the brain | 2014-3-19 | PIRAMAL IMAGING |
| 4 | Vizamyl | Flutemetamol F-18 | A radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia. | 2013-10-25 | GE HEALTHCARE |
| 5 | Xofigo | Radium Ra-223 dichloride | To treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. | 2013-5-15 | BAYER HLTHCARE |
| 6 | Lymphoseek kit | Technetium Tc-99m tilmanocept | A radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. | 2013-3-13 | NAVIDEA BIOPHARMS |
| 7 | Choline C 11 Injection | Choline C-11 | A Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. | 2012-9-12 | MCPRF |
| 8 | Amyvid | Florbetapir F-18 | Used as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are bei | 2012-4-6 | AVID RADIOPHARMS INC |
| 9 | Datscan | Ioflupane i-123 | An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). | 2011-1-14 | GE HLTHCARE INC |
| 10 | Adreview | Iobenguane sulfate I-123 | PROVIDES FOR THE DETECTION OF PRIMARY OR METASTATIC PHEOCHROMOCYTOMAS. | 2008-9-19 | GE HEALTHCARE |
| 11 | Ammonia N 13 | Ammonia N-13 | Provides for the treatment as a radioactive diagnostic agent for Positron Emission Tomography (PET), for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evalu | 2007-8-23 | FEINSTEIN |
| 12 | NeutroSpec | Technetium 99m Tc fanolesomab | NeutroSpec is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. | 2004-7-2 | Palatin Technologies Inc. |
表2. 2000年以来CFDA批准的新放射性药物
| 序号 | 国产药品名称 | 批准文号 | 生产单位 |
| 1 | 碘[131I]美妥昔单抗注射液 | S20060064 | 成都华神生物技术有限责任公司 |
| 2 | 碘[131I]肿瘤细胞核人鼠嵌合单克隆抗体注射液 | S20060061 | 上海美恩生物技术有限公司 |
| 3 | 氟[18F]脱氧葡糖注射液 | H20050441 | 原子高科股份有限公司 |
| 4 | 碘[125I]密封籽源 | H20045969 | 原子高科股份有限公司 |
| 5 | 氯化锶[89Sr]注射液 | H20041312 | 上海原子科兴药业有限公司 |
| 6 | 来昔决南钐[153Sm]注射液 | H20010679 | 原子高科股份有限公司 |
| 7 | 锝[99Tc]亚甲基二膦酸盐注射液 | H20000218 | 成都云克药业有限责任公司 |
上一篇： FDA批准的放射性药物都有哪些
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