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2018 年 FDA 首仿药清单小结
【编者按】多年来，首仿药意味着价格比品牌药略低但远高于一般仿制药，意味着抢占市场……现如今对于越来越多的复杂产品来说，首仿更意味着一种鼓励、一种证明，当前技术可以成功地开发出与复杂产品等效的仿制药。FDA多批快批首仿药，并提高透明度，有助于企业，更有益于民众。
仿制药计划的目的是最终批准多个仿制产品，从而促进市场竞争，降低药价，增加患者的可及性。虽然首仿批准将不会大幅降低药价，通常仅是品牌药价格的 70% 左右。但随着越来越多的仿制药获批，价格将迅速下降，这才是仿制药计划的最终目标。
截至 2018 年 7 月美国 FDA 共批准 47 个首仿药，其中前六个月仅批准了 34 个首仿药，平均每月 5.6 个，似乎看起来进展缓慢，但 7 月一个月批准了 13 个。虽然 7 月份是首仿批准的突出月份，但是很难判断其中有多少是真正的首轮批准。还有一些可能是之前获得暂时批准然后于七月份获得完全批准。虽然 FDA 在仿制药计划行动月度报告中提供了首轮批准的数量，但并没有指明哪些产品是首轮批准。
|
| ANDA 号
| 仿制药名称
| ANDA 申请人
| 品牌药名
| ANDA 批准日期
| ANDA 适应症
|
| 47
| 203153
| TemsiroLimus Injection, 25 mg/ml Single Dose Vial
| Accord Healthcare Inc.
| Torisel(Temsirolimus)Injection, 25mg/ml
| 7/30/2018
| 用于治疗晚期肾细胞癌
|
| 46
| 209549
| Teriflunomide Tablets, 7 mg, 14 mg
| Watson Laboratories, Inc.
| Aubagio (Teriflunomide) Tablets, 7 mg, 14 mg
| 7/27/2018
| 用于治疗复发型多发性硬化症
|
| 45
| 202586
| Indium in 111 Oxyquinoline Solution, USP, 1 mCi/mL
| Nordion (Canada), inc.
| Indium in 111 Oxyquinoline Solution, 1 mCi/mL
| 7/25/2018
| 用于放射性标记自体白细胞
|
| 44
| 207630
| Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2% / 0.5% PF
| Aurobindo Pharma Limited
| Cosopt (Dorzolamide Hydrochloride and Timolol Maleate) Ophthalmic Solution, 2% / 0.5% PF
| 7/24/2018
| 用于降低对β受体阻滞剂反应不足的开角型青光眼或高眼压患者的眼压升高
|
| 43
| 209107
| Cetirizine Hydrochloride Capsules, 10 mg
| Aurobindo Pharma Limited
| Cetirizine Hydrochloride Capsules, 10 mg
| 7/20/2018
| 用于暂时缓解由花粉症或其它呼吸道过敏症引发的症状：流鼻涕、瘙痒、流泪、打喷嚏、鼻子或喉咙发痒
|
| 42
| 206107
| Asenapine Sublingual Tablets, 5 mg, 10 mg
| Sigmapharm Laboratories, LLC
| Saphris (Asenapine) Sublingual Tablets, 5 mg, 10 mg
| 7/17/2018
| 作为锂或丙戊酸的辅助治疗，用于治疗成人双相 I 型障碍
|
| 41
| 209448
| Dextrose Injection, 10%
| Fresenius Kabi USA, LLC
| Dextrose Injection USP, 10%
| 7/16/2018
| 用于治疗低血糖症
|
| 40
| 204393
| Morphine Sulfate Injection USP, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials
| Piramal Critical Care Limited
| Infumorph (Morphine Sulfate) Injection, 200 mg/20 mL (10 mg/mL) Single Use Vials; 500 mg/20 mL (25 mg/mL) Single Use Vials
| 7/16/2018
| 用于严重到需要通过静脉给予阿片类镇痛药且替代治疗不足的疼痛管理；用于不伴随运送、感觉或交感神经功能丧失的硬膜外或鞘内疼痛管理
|
| 39
| 202190
| Colesevelam Hydrochloride for Oral Suspension, 1.875 g/packet, 3.75 g/packet
| Glenmark Pharmaceuticals Limited
| Welchol (Colesevelam Hydrochloride) for Oral Suspension, 1.875 g/packet, 3.75 g/packet
| 7/16/2018
| 在某些原发性高脂血症的成人患者中作为单独治疗药物以及在伴有杂合子家族性高胆固醇血症的男孩和初潮后的女孩（10岁到17岁）中，降低低密度脂蛋白胆固醇（LDL-C）的升高
|
| 38
| 20257
| Roflumilast Tablets, 500 mcg
| Mylan Pharmaceuticals
| Daliresp (Roflumilast) Tablets, 500 mcg
| 7/13/2018
| 降低与慢性支气管炎相关的严重 COPD 并且有病情恶化史的患者的 COPD 恶化风险
|
| 37
| 207568
| Epinephrine Injection, 1 mg/mL
| Luitpold Pharmaceuticals, Inc
| Adrenalin (Epinephrine) Injection, 1 mg/mL
| 7/6/2018
| 用于过敏反应的紧急治疗，包括过敏性休克
|
| 36
| 205457
| Budesonide Extended-Release Tablets, 9 mg
| Actavis Laboratories FL, Inc.
| Uceris (Budesonide) Extended Release Tablets, 9 mg
| 7/5/2018
| 用于轻度至中度活跃溃疡性结肠炎患者的诱导缓解
|
| 35
| 91168
| Emtricitabine capsules, 200 mg
| Cipla Limited
| Emtriva (Emtricitabine) Capsules, 200 mg
| 7/2/2018
| 与其它逆转录病毒药物联合治疗 HIV-1 感染
|
| 34
| 210723
| Hydroxyprogesterone Caproate Injection USP, 250 mg/mL Single-dose Vials
| Luitpold Pharmaceuticals, Inc.
| Makena (Hydroxyprogesterone Caproate) Injection USP, 250 mg/mL Single-dose Vials
| 6/21/2018
| 用于降低有单胎自发性早产史的单胎妊娠女性早产的风险
|
| 33
| 207607
| Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg
| Mylan Technologies Inc.
| Suboxone (Buprenorphine and Naloxone) Sublingual Film, 8 mg/2 mg and 12 mg/3 mg
| 6/14/2018
| 用于治疗阿片类药物依赖
|
| 32
| 205806
| Buprenorphine and Naloxone Sublingual Film, 4 mg/1 mg and 12 mg/3 mg
| Dr. Reddy's Laboratories SA
| Suboxone (Buprenorphine and Naloxone) Sublingual Film, 4 mg/1 mg and 12 mg/3 mg
| 6/14/2018
| 用于治疗阿片类药物依赖
|
| 31
| 205299
| Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg
| Dr. Reddy's Laboratories SA
| Suboxone (Buprenorphine and Naloxone) Sublingual Film, 2 mg/0.5 mg and 8 mg/2 mg
| 6/14/2018
| 用于治疗阿片类药物依赖
|
| 30
| 206166
| Ropivacaine Hydrochloride Injection USP, 200 mg/100 mL (2 mg/mL), 500 mg/100 mL (5 mg/mL), 400 mg/200 mL (2 mg/mL), and 1,000 mg/200 mL (5 mg/mL) Infusion Bags
| Inforlife SA
| Naropin (Ropivacaine Hydrochloride) Injection USP, 200 mg/100 mL (2 mg/mL), 500 mg/100 mL (5 mg/mL), 400 mg/200 mL (2 mg/mL), and 1,000 mg/200 mL (5 mg/mL) Infusion Bags
| 6/11/2018
| 用于手术和急性疼痛管理的局部或区域麻醉
|
| 29
| 207107
| Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg / 250 mL (10 mg/mL) and 2,000 mg/100 mL (20 mg/mL)
| Sagent Pharmaceuticals, Inc.
| Brevibloc (Esmolol Hydrochloride in Sodium Chloride) Injection, 2,500 mg / 250 mL (10 mg/mL) and 2,000 mg/100 mL (20 mg/mL)
| 6/8/2018
| 用于室上性心动过速（包括心房颤动和心房扑动）的心室率的控制的短期治疗，以及非康复性窦性心动过速的心率控制；围手术期心动过速和高血压的控制
|
| 28
| 206608
| Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag
| Mylan Pharmaceuticals
| Brevibloc (Esmolol Hydrochloride in Sodium Chloride) Injection, 2,500 mg/250mL (10 mg/mL) Single-Dose Plastic Bag, and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag
| 6/8/2018
| 用于室上性心动过速（包括心房颤动和心房扑动）的心室率的控制的短期治疗，以及非康复性窦性心动过速的心率控制；围手术期心动过速和高血压的控制
|
| 27
| 208683
| Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75%
| Taro Pharmaceuticals U.S.A., Inc.
| Onexto (Clindamycin Phosphate and Benzoyl Peroxide) gel, 1.2%/3.75%
| 6/5/2018
| 用于 12 岁及以上患者寻常性痤疮的局部治疗
|
| 26
| 207329
| Oxybutynin Chloride Gel, 10%
| Par Pharmaceutical, Inc.
| Gelnique (Oxybutynin Chloride) Gel, 10%
| 5/31/2018
| 用于治疗伴有急迫性尿失禁、尿急和尿频症状的膀胱过度活动症
|
| 25
| 090141
| Tadalafil TabletsUSP, 2.5 mg, 5 mg, 10 mg, and 20 mg
| Teva Pharmaceutical USA, Inc.
| Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg
| 5/22/2018
| 用于治疗勃起功能障碍（ED），良性前列腺增生（BPH）体征和症状
|
| 24
| 206049
| Methylphenidate Hydrochloride for Extended-Release Oral Suspension,300 mg/60 mL total volume, 600 mg/120 mL total volume, 750 mg/150 mL total volume, and 900 mg/180 mL total volume (5 mg/mL)
| Actavis Laboratories FL, Inc.
| QUILLIVANT XR® (Methylphenidate Hydrochloride) for Extended-Release Oral Suspension, 25 mg per 5 mL
| 5/17/2018
| 用于治疗注意力缺陷多动障碍（ADHD）
|
| 23
| 091600
| Colesevelam Hydrochloride Tablets, 625 mg
| Impax Laboratories, Inc.
| Welchol (Colesevelam Hydrochloride)Tablets, 625 mg
| 5/16/2018
| 在某些原发性高脂血症的成人患者中作为单独治疗药物以及在伴有杂合子家族性高胆固醇血症的男孩和初潮后的女孩（10岁到17岁）中，降低低密度脂蛋白胆固醇（LDL-C）的升高
|
| 22
| 209373
| Phytonadione Tablets USP, 5 mg
| Amneal Pharmaceuticals Company GmbH
| Mephyton (Phytonadione) Tablets, 5 mg
| 5/11/2018
| 用于治疗由香豆素或茚满二酮衍生物引起的抗凝血剂诱导的凝血酶原缺乏症，继抗生素治疗的低凝血酶原血症，继施用水杨酸盐后的低凝血酶原血症，继发于阻塞性黄疸或胆瘘的某些低凝血酶原血症
|
| 21
| 209467
| Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials
| Zydus Pharmaceuticals (USA), Inc.
| Quelicin (Succinylcholine Chloride) Injection USP, 200 mg/10 mL (20 mg/mL) Multiple-Dose Vials
| 5/4/2018
| 作为全身麻醉的辅助手段以便于气管插管，并在手术或器械通气期间提供骨骼肌松弛
|
| 20
| 210334
| Phenylephrine Hydrochloride Injection USP, 10 mg/mL SingleDose Via
| Cipla Limited
| Phenylephrine Hydrochloride
| 4/27/2018
| 用于患有临床重要的低血压的成人患者升高血压，这类低血压主要由感染性休克或麻醉等环境中的血管舒张所致
|
| 19
| 210333
| Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package
| Cipla Limited
| Vazculep (Phenylephrine Hydrochloride) Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package
| 4/27/2018
| 用于治疗主要是麻醉环境血管舒张所致的临床重要的低血压
|
| 18
| 202159
| Hydromorphone Hydrochloride Injection USP, 2 mg/mL Single-Dose Vial
| Eurohealth International Sarl
| Dilaudid (Hydromorphone Hydrochloride) Injection USP, 2 mg/mL Single-Dose Vial
| 4/27/2018
| 用于严重到需要通过静脉给予阿片类镇痛药且替代治疗不足的疼痛管理
|
| 17
| 208342
| Miglustat Capsules, 100 mg
| Amerigen Pharmaceuticals Limited
| Zavesca (Miglustat) Capsules, 100 mg
| 4/17/2018
| 用于治疗患有轻度/中度 1 型谢戈病且酶替代疗法不是治疗选择的成年患者
|
| 16
| 210088
| Loratadine Chewable Tablets USP, 5 mg (OTC)
| Sun Pharma Global FZE
| Children's Claritin (Loratadine) Chewable Tablets, 5 mg
| 4/16/2018
| 用于季节性过敏性鼻炎和特发性荨麻疹
|
| 15
| 208790
| Ertapenem for Injection, 1 gram (base)/ Single-dose vial
| ACS DOBFAR SPA
| Invanz (Ertapenem) for Injection, 1 gram (base)/ Single-dose vial
| 4/16/2018
| 用于治疗由易感细菌引起的某些中度至重度感染
|
| 14
| 206133
| Everolimus Tablets, 0.25 mg, 0.5 mg, and 0.75 mg
| West-Ward Pharmaceuticals International Limited
| Zortress (Everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 m
| 4/12/2018
| 用于低中度免疫风险的肾移植患者的器官排斥预防
|
| 13
| 090308
| Clozapine Orally Disintegrating Tablets, 12.5 mg
| Barr Laboratories Inc.
| Fazaclo (Clozapine) Orally Disintegrating Tablets, 12.5 mg
| 4/9/2018
| 用作抗精神病药物
|
| 12
| 204636
| Ropivacaine Hydrochloride Injection USP, 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles
| Akorn Inc.
| Naropin (Ropivacaine Hydrochloride Injection USP), 0.2%, 200 mg/100 mL and 400 mg/200 mL (2 mg/mL), single-dose infusion bottles
| 3/16/2018
| 用于局部、区域麻醉和急性疼痛管理
|
| 11
| 208915
| Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base), and 90 mg (base)
| Cipla Limited
| Sensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg (base)
| 3/8/2018
| 用于治疗成人慢性肾病患者的继发性甲状腺功能亢进（HPT），成人甲状旁腺癌（PC）患者的高钙血症，以及无法接受甲状旁腺切除术的原发性 HPT 患者的严重高钙血症
|
| 10
| 206125
| Cinacalcet Hydrochloride Tablets, 30 mg (base), 60 mg (base) and 90 mg (base)
| Aurobindo Pharma Limited
| Sensipar Tablets, 30 mg (base), 60 mg (base), and 90 mg
| 3/8/2018
| 用于治疗成人慢性肾病患者的继发性甲状腺功能亢进（HPT），成人甲状旁腺癌（PC）患者的高钙血症，以及无法接受甲状旁腺切除术的原发性 HPT 患者的严重高钙血症
|
| 9
| 209594
| Baclofen Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials
| Mylan Laboratories Limited
| Gablofen (Baclofen) Injection, 20,000 mcg/20 mL (1,000 mcg/mL) Single-dose Vials
| 3/6/2018
| 用于治疗成人和 4 岁及以上儿科患者的脑或脊髓严重痉挛
|
| 8
| 208234
| Desflurane USP, Liquid for Inhalation
| Shanghai Hengrui Pharmaceutical Co., Ltd.
| Suprane (Desflurane USP), Liquid for Inhalation
| 2/26/2018
| 适用于全身麻醉
|
| 7
| 207457
| Sumatriptan and Naproxen Tablets, 85 mg/500 mg
| Aurobindo Pharma Limited
| Treximet (Sumatriptan and Naproxen) Tablets, 85 mg/500 mg
| 2/15/2018
| 用于成人有或没有先兆的偏头痛的急性治疗
|
| 6
| 207567
| Trientine Hydrochloride Capsules USP, 250 mg
| Watson Laboratories, Inc
| Syprine (Trientine Hydrochloride) Capsules USP, 250 mg
| 2/7/2018
| 用于不耐受青霉胺威尔森氏病患者的治疗。由于无法忍受或危及生命的副作用，不再可能继续使用青霉胺治疗时应使用 Syprine\
|
| 5
| 091612
| Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg
| Teva Pharmaceuticals USA, Inc.
| Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg
| 1/26/2018
| 用于治疗 HIV-1 感染；用于治疗慢性乙型肝炎
|
| 4
| 090647
| Tenofovir Disoproxil Fumarate Tablets, 150 mg, 200 mg, 250 mg
| Aurobindo Pharma Limited
| Viread (Tenofovir Disoproxil Fumarate) Tablets, 150 mg, 200 mg, and 250 mg
| 1/26/2018
| 与其它抗逆转录病毒药物联合使用，用于治疗成人和 2 岁及以上儿童患者的 HIV-1 感染。适用于成人和 12 岁及以上儿童患者的慢性乙型肝炎
|
| 3
| 210375
| Levocetirizine Dihydrochloride Tablets USP, 5 mg
| Dr. Reddy's Laboratories Limited
| Xyzal (Levocetirizine Dihydrochloride Tablets USP, 5 mg) Allergy 24HR
| 1/19/2018
| 用于暂时缓解由花粉症或其它呼吸道过敏症引发的症状：流鼻涕、瘙痒、流泪、打喷嚏、鼻子或喉咙发痒
|
| 2
| 206223
| Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial
| Fresenius Kabi USA, LLC
| Ultiva® Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial
| 1/16/2018
| 静脉给药：用于住院和门诊手术的全身麻醉诱导和维持期间的镇痛剂；在麻醉后监护室或重症监护室，麻醉医师直接监督下，成人患者术后即刻继续作为镇痛药；作为成人患者需监测的麻醉护理的镇痛成分
|
| 1
| 209688
| Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)
| Paddock LLC
| K-Tab (Potassium Chloride Extended-Release Tablets) USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)
| 1/12/2018
| 用于伴有或没有代谢性碱中毒、洋地黄中毒的低钾血症患者治疗，以及低钾性周期性麻痹患者；对于如发生低钾血症可能有特别风险的患者（用毛地黄治疗心脏病的患者或有严重心律失常的患者），可预防低钾血症
|
