新增FDA《特定药物的生物等效性指导原则》品种列表
编号 | 英文名称 | 药品名称 | 剂型/给药途径 | 原文链接 |
1 | Amphotericin B | 脂质体注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384094.pdf | |
2 | Aripiprazole | 缓释混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428196.pdf | |
3 | Azacitidine | 注射剂/静脉或皮下注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM082801.pdf | |
4 | Betamethasone Acetate; Betamethasone Sodium Phosphate | 注射剂/皮下或肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209219.pdf | |
5 | Dalteparin Sodium | 注射剂/皮下注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319988.pdf | |
6 | Dantrolene sodium | 混悬注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM572991.pdf | |
7 | Daunorubicin citrate | 脂质体注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406256.pdf | |
8 | Doxorubicin hydrochloride | 脂质体注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199635.pdf | |
9 | Enoxaparin Sodium | 注射剂/皮下注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM277709.pdf | |
10 | Epinephrine | 注射剂/皮下或肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM534133.pdf | |
11 | 注射剂/皮下或肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM573009.pdf | ||
12 | Ethiodized oil | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM533302.pdf | |
13 | Ferric carboxymaltose | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495022.pdf | |
14 | Ferumoxytol | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333051.pdf | |
15 | Fulvestrant | 注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296897.pdf | |
16 | 注射剂/皮下注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495029.pdf | ||
17 | Iron dextran | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM520240.pdf | |
18 | Iron Sucrose | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM297630.pdf | |
19 | Lanreotide Acetate | 注射剂/皮下注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406278.pdf | |
20 | Leuprolide Acetate | 注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM212614.pdf | |
21 | Leuprolide Acetate | 注射微球/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM212615.pdf | |
22 | Medroxyprogesterone Acetate | 混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358126.pdf | |
23 | Medroxyprogesterone Acetate | 混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358133.pdf | |
24 | Methylprednisolone acetate | 混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162434.pdf | |
25 | 缓释混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM179182.pdf | ||
26 | Octreotide acetate | 注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240975.pdf | |
27 | Olanzapine pamoate | 缓释混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM481944.pdf | |
28 | Paclitaxel | 混悬型注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320015.pdf | |
29 | Paliperidone Palmitate | 缓释混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM270384.pdf | |
30 | Phytonadione | 注射剂/皮下注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162462.pdf | |
31 | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM506910.pdf | ||
32 | Risperidone | 注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201272.pdf | |
33 | Sodium Ferric Gluconate Complex | 注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358142.pdf | |
34 | Triamcinolone Acetonide | 混悬注射剂/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM179193.pdf | |
35 | Triptorelin Pamoate | 注射液/肌内注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090738.pdf | |
36 | Verteporfin | 脂质体注射剂/静脉注射 | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384173.pdf | |
37 | Angiotensin II Acetate | 溶液/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/ANGIOTENSIN II ACETATE IV infusion solution NDA 209360 RC Feb 2019.pdf | |
38 | Bupivacaine | 脂质体注射剂/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupivacaine_ liposomal injectable injection_NDA 022496_RC11-17.pdf | |
39 | Daptomycin | 注射用粉末/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/DAPTOMYCIN IV infusion powder NDA 209949 & NDA 208385 Page Feb 2019.pdf | |
40 | Epinephrine | 注射剂/肌肉或皮下 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_draft_Intramuscular subcutaneous solution_RLD 207534_RC07-18.pdf | |
41 | Fish oil; Medium chain triglycerides; Olive oil; Soybean oil | 乳剂/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fish oil; Medium chain triglycerides; Olive oil; Soybean oil NDA 207648 Feb 2019.pdf | |
42 | Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride | 粉末/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosnetupitant and Palonosetron Hydrochloride, powder for injection NDA 210493 PSG Page RC May 2019.pdf | |
43 | Letermovir | 溶液/静脉输注 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letermovir_IV_infusion_solution_NDA_209940_RC_Oct_2018.pdf | |
44 | Leuprolide Acetate; Norethindrone Acetate | 注射剂/肌内 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leuprolide_acetate_Norethindrone_acetate_NDA_203696_ RC11-17.pdf | |
45 | Olive Oil; Soybean Oil | 注射剂 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Olive oil; Soybean Oil injectable injection RLD 204508 RC 09-2018.pdf | |
46 | Perflutren | 注射剂/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Perflutren Liposomal Injection RLD 021064 RC 09-2018 .pdf | |
47 | Soybean Oil | 注射剂 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean oil_injectable injection_NDA 019531_RC11-17.pdf | |
48 | Soybean Oil | 注射剂 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean oil_injectable injection_NDA 020248, 018449, 017643_RC11-17.pdf | |
49 | Sulfasalazine | 混悬液/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfasalazine_tab_07073_RC2-10.pdf | |
50 | Triamcinolone acetonide | 注射剂/静脉 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_intravitreal injectable_NDA 022048_RC07-18.pdf |