FDA特殊注射剂生物等效性指导原则(译文)

发布时间:2018-02-09

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

两性霉素B

脂质体注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384094.pdf

2

Aripiprazole

阿立哌唑

缓释混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428196.pdf

3

Azacitidine

阿扎胞苷

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

乙酸倍他米松;倍他米松磷酸钠

注射剂/皮下或肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209219.pdf

5

Dalteparin     Sodium

达肝素钠

注射剂/皮下注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319988.pdf

6

Dantrolene     sodium

丹曲林钠

混悬注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM572991.pdf

7

Daunorubicin     citrate

枸橼酸柔红霉素

脂质体注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406256.pdf

8

Doxorubicin     hydrochloride

盐酸多柔比星

脂质体注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM199635.pdf

9

Enoxaparin     Sodium

依诺肝素钠

注射剂/皮下注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM277709.pdf

10

Epinephrine

肾上腺素

注射剂/皮下或肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM534133.pdf

11

Epinephrine

肾上腺素

注射剂/皮下或肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM573009.pdf

12

Ethiodized     oil

乙碘油

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM533302.pdf

13

Ferric     carboxymaltose

羟基麦芽糖铁

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495022.pdf

14

Ferumoxytol

纳米氧化铁

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333051.pdf

15

Fulvestrant

氟维司群

注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296897.pdf

16

Glatiramer acetate

醋酸格拉替雷

注射剂/皮下注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495029.pdf

17

Iron     dextran

右旋糖酐铁

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM520240.pdf

18

Iron     Sucrose

蔗糖铁

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM297630.pdf

19

Lanreotide     Acetate

醋酸兰瑞肽

注射剂/皮下注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406278.pdf

20

Leuprolide     Acetate

醋酸亮丙瑞林

注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM212614.pdf

21

Leuprolide     Acetate

醋酸亮丙瑞林

注射微球/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM212615.pdf

22

Medroxyprogesterone     Acetate

醋酸甲羟孕酮

混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358126.pdf

23

Medroxyprogesterone     Acetate

醋酸甲羟孕酮

混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358133.pdf

24

Methylprednisolone     acetate

醋酸甲泼尼龙

混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162434.pdf

25

naltrexone

纳曲酮

缓释混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM179182.pdf

26

Octreotide     acetate

醋酸奥曲肽

注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240975.pdf

27

Olanzapine     pamoate

双羟萘酸奥氮平

缓释混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM481944.pdf

28

Paclitaxel

紫杉醇

混悬型注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320015.pdf

29

Paliperidone     Palmitate

棕榈酸帕潘立酮

缓释混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM270384.pdf

30

Phytonadione

维生素K1

注射剂/皮下注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM162462.pdf

31

Propofol

异丙酚

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM506910.pdf

32

Risperidone

利培酮

注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201272.pdf

33

Sodium     Ferric Gluconate Complex

复合葡萄糖酸钠铁

注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358142.pdf

34

Triamcinolone     Acetonide

曲安奈德

混悬注射剂/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM179193.pdf

35

Triptorelin     Pamoate

双羟萘酸曲普瑞林

注射液/肌内注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM090738.pdf

36

Verteporfin

维替泊芬

脂质体注射剂/静脉注射

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384173.pdf

37

Angiotensin     II Acetate

醋酸血管紧张素II

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

布比卡因

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

达托霉素

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

肾上腺素

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

鱼油;中链甘油三酸酯;橄榄油;大豆

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

盐酸磷尼曲坦;盐酸帕洛诺司琼

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

乐特莫韦

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

醋酸亮丙瑞林,醋酸炔诺酮

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

橄榄油;大豆油

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

八氟丙烷

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

大豆油

注射剂

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean     oil_injectable injection_NDA 019531_RC11-17.pdf

48

Soybean     Oil

大豆油

注射剂

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Soybean     oil_injectable injection_NDA 020248, 018449, 017643_RC11-17.pdf

49

Sulfasalazine

六氟化硫脂A型微球

混悬液/静脉

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfasalazine_tab_07073_RC2-10.pdf

50

Triamcinolone     acetonide

醋酸曲安奈德

注射剂/静脉

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone     acetonide_intravitreal injectable_NDA 022048_RC07-18.pdf