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每周药品注册获批数据，分门别类呈现，一目了然。(8.25-8.31） 新药上市申请 药品名称 企业 注册分类 受理号 达希替尼片 轩竹生物科技股份有限公司 1 CXHS2400036 达希替尼片 轩竹生物科技股份有限公司 1 CXHS2400035 注射用苯磺酸瑞马唑仑 宜昌人福药业有限责任公司 2.4 CXHS2400093 注射用苯磺酸瑞马唑仑 宜昌人福药业有限责任公司 2.4 CXHS2400092 口服六价重配轮状病毒活疫苗(Vero细胞) 武汉生物制品研究所有限责任公司 1.4 CXSS2300039 鼻喷流感减毒活疫苗 长春百克生物科技股份公司 3.2 CXSS2400043 新药临床申请 药品名称 企业 注册分类 受理号 TQB3201片 正大天晴药业集团股份有限公司 1 CXHL2500775 TQB3201片 正大天晴药业集团股份有限公司 1 CXHL2500774 SH3765片 南京圣和药业股份有限公司 1 CXHL2500631 AXT-1003胶囊 艾斯拓康医药科技(北京)有限公司 1 CXHL2500618 Sonrotoclax薄膜包衣片 百济神州(苏州)生物科技有限公司 1 CXHL2500617 Sonrotoclax薄膜包衣片 百济神州(苏州)生物科技有限公司 1 CXHL2500616 Sonrotoclax薄膜包衣片 百济神州(苏州)生物科技有限公司 1 CXHL2500615 Sonrotoclax薄膜包衣片 百济神州(苏州)生物科技有限公司 1 CXHL2500614 HS-10241片 江苏豪森药业集团有限公司 1 CXHL2500608 HS-10241片 江苏豪森药业集团有限公司 1 CXHL2500607 CX1440胶囊 杭州邦顺制药有限公司 1 CXHL2500603 CX1440胶囊 杭州邦顺制药有限公司 1 CXHL2500602 BAY 3713372 片 拜耳医药保健有限公司 1 CXHL2500596 BAY 3713372 片 拜耳医药保健有限公司 1 CXHL2500595 磷酸泊沃昔替尼片 海南德镁医药科技有限责任公司 1 CXHL2500599 磷酸泊沃昔替尼片 海南德镁医药科技有限责任公司 1 CXHL2500598 磷酸泊沃昔替尼片 海南德镁医药科技有限责任公司 1 CXHL2500597 雷美替胺双释片 南京三迭纪医药科技有限公司 2.2 CXHL2500590 SN007干混悬剂 上海惠永制药有限公司 2.2 CXHL2500539 注射用西罗莫司(白蛋白结合型) 石药集团中奇制药技术(石家庄)有限公司 2.2;2.4 CXHL2500586 NT-INF-001制剂 嘉译生物医药(杭州)有限公司 1.2 CXSL2500468 注射用TQB2934(皮下注射) 正大天晴药业集团南京顺欣制药有限公司 1 CXSL2500517 注射用SHR-1826 苏州盛迪亚生物医药有限公司 1 CXSL2500504 CM336注射液 康诺亚生物医药科技(成都)有限公司 1 CXSL2500503 SY-005注射液 苏州亚宝药物研发有限公司 1 CXSL2500489 GKL-006Allo注射液 北京基因启明生物科技有限公司 1 CXSL2500475 脐带血巨核细胞注射液 苏州血霁生物科技有限公司 1 CXSL2500465 人羊膜间充质干细胞注射液 源品细胞生物科技集团有限公司 1 CXSL2500464 LYN101注射液 上海才致药成生物科技有限公司 1 CXSL2500456 培集成干扰素α-2注射液 北京凯因科技股份有限公司 2.2 CXSL2500518 阿得贝利单抗注射液 上海盛迪医药有限公司 2.2 CXSL2500506 贝伐珠单抗注射液 苏州盛迪亚生物医药有限公司 2.2 CXSL2500505 仿制药申请 药品名称 企业 注册分类 受理号 盐酸苯海拉明注射液 苏州朗科生物技术股份有限公司 3 CYHS2404513 盐酸苯海拉明注射液 苏州朗科生物技术股份有限公司 3 CYHS2404512 氨磺必利注射液 南京正科医药股份有限公司 3 CYHS2401488 二羟丙茶碱注射液 峨眉山通惠制药有限公司 3 CYHS2401474 氨磺必利注射液 南京正科医药股份有限公司 3 CYHS2401487 草酸艾司西酞普兰口服滴剂 广州一品红制药有限公司 3 CYHS2400930 二羟丙茶碱注射液 辽宁海神联盛制药有限公司 3 CYHS2400728 二羟丙茶碱注射液 山东睿亿医药有限公司 3 CYHS2400727 氯化钾缓释片 天津力生制药股份有限公司 3 CYHS2400678 氯化钾缓释片 天津力生制药股份有限公司 3 CYHS2400677 盐酸左沙丁胺醇雾化吸入溶液 海南斯达制药有限公司 3 CYHS2400516 硫酸镁注射液 江苏迪赛诺制药有限公司 3 CYHS2400511 吲哚布芬片 金鸿药业股份有限公司 3 CYHS2400317 吡拉西坦注射液 西安达莫制药有限公司 3 CYHS2400332 吡拉西坦注射液 西安达莫制药有限公司 3 CYHS2400331 注射用尼可地尔 朗天药业(湖北)有限公司 3 CYHS2400232 左氧氟沙星注射液 昆明南疆制药有限公司 3 CYHS2400169 左氧氟沙星注射液 昆明南疆制药有限公司 3 CYHS2400168 硫辛酸片 浙江花园药业有限公司 3 CYHS2400002 硫辛酸片 浙江花园药业有限公司 3 CYHS2400003 盐酸西替利嗪口服溶液 重庆健能医药开发有限公司 3 CYHS2303519 盐酸西替利嗪口服溶液 重庆健能医药开发有限公司 3 CYHS2303518 重酒石酸去甲肾上腺素注射液 嘉实(湖南)医药科技有限公司 3 CYHS2303040 重酒石酸去甲肾上腺素注射液 嘉实(湖南)医药科技有限公司 3 CYHS2303041 米诺地尔搽剂 山东新华制药股份有限公司 3 CYHS2302643 米诺地尔搽剂 山东新华制药股份有限公司 3 CYHS2302644 盐酸左西替利嗪口服溶液 海南斯达制药有限公司 3 CYHS2302005 米诺地尔外用溶液 华润三九医药股份有限公司 3 CYHS2301548 二氟泼尼酯滴眼液 天津金耀药业有限公司 3 CYHS2101727国;CYHS2101727 硫酸氨基葡萄糖胶囊 河南羚锐制药股份有限公司 4 CYHS2502538 瑞维那新吸入溶液 遂成药业股份有限公司 4 CYHS2502515 乌帕替尼缓释片 山东齐都药业有限公司 4 CYHS2404262 氧 麻栗坡县民华燃气有限公司 4 CYHS2403642 地夸磷索钠滴眼液 四川美大康华康药业有限公司 4 CYHS2402032 左卡尼汀注射液 浙江北生药业汉生制药有限公司 4 CYHS2402027 盐酸奥洛他定滴眼液 江西马应龙美康药业有限公司 4 CYHS2401840 依折麦布阿托伐他汀钙片(I) 成都倍特药业股份有限公司 4 CYHS2401670 依折麦布阿托伐他汀钙片(II) 成都倍特药业股份有限公司 4 CYHS2401669 硫酸氨基葡萄糖胶囊 山西复盛公大药厂有限公司 4 CYHS2401637 枸橼酸托法替布缓释片 华润双鹤利民药业(济南)有限公司 4 CYHS2401589 吸入用异丙托溴铵溶液 广州大光制药有限公司 4 CYHS2401580 甲巯咪唑片 江苏德源药业股份有限公司 4 CYHS2401563 阿司匹林肠溶片 江苏济茗医药有限公司 4 CYHS2401526 酒石酸溴莫尼定滴眼液 浙江赛默制药有限公司 4 CYHS2401462 沙库巴曲缬沙坦钠片 山东新华制药股份有限公司 4 CYHS2401428 枸橼酸西地那非片 南京正科医药股份有限公司 4 CYHS2401420 枸橼酸西地那非片 南京正科医药股份有限公司 4 CYHS2401418 枸橼酸西地那非片 南京正科医药股份有限公司 4 CYHS2401417 单硝酸异山梨酯片 珠海润都制药股份有限公司 4 CYHS2401415 非布司他片 四川依科制药有限公司 4 CYHS2401413 非布司他片 四川依科制药有限公司 4 CYHS2401412 盐酸贝尼地平片 石家庄四药有限公司 4 CYHS2401408 盐酸奥布卡因滴眼液 浙江视方极医药科技有限公司 4 CYHS2401399 骨化三醇软胶囊 浙江浙北药业有限公司 4 CYHS2401354 磷酸奥司他韦胶囊 陕西步长高新制药有限公司 4 CYHS2401342 盐酸达泊西汀片 苏州特瑞药业股份有限公司 4 CYHS2401292 他达拉非片 重庆康刻尔制药股份有限公司 4 CYHS2401283 他达拉非片 重庆康刻尔制药股份有限公司 4 CYHS2401282 盐酸屈他维林注射液 北京新美泰克医药科技有限公司 4 CYHS2401267 氧(液态) 吉林杭氧气体有限公司 4 CYHS2401196 二甲硅油乳剂 陕西丽彩药业有限公司 4 CYHS2401150 二甲硅油乳剂 陕西丽彩药业有限公司 4 CYHS2401149 二甲硅油乳剂 陕西丽彩药业有限公司 4 CYHS2401147 硫酸镁钠钾口服用浓溶液 广东大冢制药有限公司 4 CYHS2401114 硫酸镁钠钾口服用浓溶液 浙江凯润药业股份有限公司 4 CYHS2401056 左甲状腺素钠片 北京福元医药股份有限公司 4 CYHS2400924 莫匹罗星软膏 深圳市泰力生物医药有限公司 4 CYHS2400909 硫酸镁钠钾口服用浓溶液 山东京卫制药有限公司 4 CYHS2400908 醋酸加尼瑞克注射液 广东粤和泽药物研究有限公司 4 CYHS2400808 左氧氟沙星滴眼液 河北合渡药业有限公司 4 CYHS2400806 注射用氟氧头孢钠 浙江惠迪森药业有限公司 4 CYHS2400810 复方氨基酸注射液(18AA-IX) 广东赛烽医药科技有限公司 4 CYHS2400805 比索洛尔氨氯地平片 浙江花园药业有限公司 4 CYHS2400784 长链脂肪乳注射液(OO) 四川科伦药业股份有限公司 4 CYHS2400748 长链脂肪乳注射液(OO) 四川科伦药业股份有限公司 4 CYHS2400747 盐酸奥布卡因滴眼液 广州大光制药有限公司 4 CYHS2400703 复方氨基酸注射液(18AA-VII) 广东赛烽医药科技有限公司 4 CYHS2400702 甲钴胺片 山东鲁宁药业有限公司 4 CYHS2400593 沙库巴曲缬沙坦钠片 重庆圣华曦药业股份有限公司 4 CYHS2400591 沙库巴曲缬沙坦钠片 重庆圣华曦药业股份有限公司 4 CYHS2400590 舒更葡糖钠注射液 乳源东阳光药业有限公司 4 CYHS2400462 盐酸多奈哌齐片 山东新时代药业有限公司 4 CYHS2400446 盐酸多奈哌齐片 山东新时代药业有限公司 4 CYHS2400445 盐酸艾司洛尔氯化钠注射液 海南爱科制药有限公司 4 CYHS2400409 苯磺酸左氨氯地平片 合肥九研医药科技开发有限公司 4 CYHS2400372 结构脂肪乳注射液(C6-24) 四川科伦药业股份有限公司 4 CYHS2400347 注射用磷酸特地唑胺 上海谷方盟医药科技有限公司 4 CYHS2400201 吗啉硝唑氯化钠注射液 贵州科伦药业有限公司 4 CYHS2400196 盐酸尼卡地平注射液 齐鲁制药(海南)有限公司 4 CYHS2400097 富马酸伏诺拉生片 双鹤药业(海南)有限责任公司 4 CYHS2400027 富马酸伏诺拉生片 双鹤药业(海南)有限责任公司 4 CYHS2400028 左氧氟沙星片 湖北唯森制药有限公司 4 CYHS2400001 沙格列汀二甲双胍缓释片(I) 山东齐都药业有限公司 4 CYHS2303680 拉考沙胺口服溶液 岳阳新华达制药有限公司 4 CYHS2303614 克拉霉素干混悬剂 山东淄博新达制药有限公司 4 CYHS2303570 吸入用复方异丙托溴铵溶液 扬州中宝药业股份有限公司 4 CYHS2303490 环硅酸锆钠散 时森海(杭州)医药科技有限公司 4 CYHS2303462 维生素B12滴眼液 中山万汉制药有限公司 4 CYHS2303249 复方甘草酸苷片 成都倍特药业股份有限公司 4 CYHS2303133 复方甘草酸苷片 浙江美迪深生物医药有限公司 4 CYHS2303019 注射用培美曲塞二钠 北京双鹭药业股份有限公司 4 CYHS2302312 注射用培美曲塞二钠 北京双鹭药业股份有限公司 4 CYHS2302311 利丙双卡因乳膏 华润双鹤药业股份有限公司 4 CYHS2301541 结构甘油三酯 广州白云山汉方现代药业有限公司 CYHS2360922 二氟泼尼酯 津药药业股份有限公司 CXHS2060017 吸附破伤风疫苗 北京科兴中维生物技术有限公司 3.3 CXSS2400044 重组人卵泡刺激素-CTP融合蛋白注射液 苏州晟济药业有限公司 3.2 CXSS2400012 重组人卵泡刺激素-CTP融合蛋白注射液 苏州晟济药业有限公司 3.2 CXSS2400011 环孢素滴眼液(II) 鲁南贝特制药有限公司 3 CYHL2500108 盐酸毛果芸香碱滴眼液 浙江莎普健康管理有限公司 3 CYHL2500107 布地奈德福莫特罗吸入粉雾剂(II) 珠海瑞思普利医药科技有限公司 4 CYHL2500106 流感病毒裂解疫苗 武汉生物制品研究所有限责任公司 3.3 CXSL2500460 流感病毒裂解疫苗 武汉生物制品研究所有限责任公司 3.3 CXSL2500459 进口申请 药品名称 企业 注册分类 受理号 盐酸阿曲生坦片 Novartis Pharma Schweiz AG 1 JXHS2400103 注射用Datopotamab Deruxtecan Daiichi Sankyo Europe GmbH 1 JXSS2400026 布西珠单抗注射液 Novartis Pharma Schweiz AG 3.1 JXSS2400089 布西珠单抗注射液 Novartis Pharma Schweiz AG 3.1 JXSS2400088 枸橼酸西地那非片 Hetero Labs Limited 5.2 JYHS2300127 吗替麦考酚酯胶囊 Mylan Laboratories Limited 5.2 JYHS2300118 枸橼酸西地那非片 Hetero Labs Limited 5.2 JYHS2300097 枸橼酸西地那非片 Hetero Labs Limited 5.2 JYHS2300096 枸橼酸西地那非片 Hetero Labs Limited 5.2 JYHS2300095 锝[Tc 99m]喷替酸盐注射液制备试剂盒 Curium Netherlands B.V. 5.2 JYHS2200067国;JYHS2200067 Centanafadine持释胶囊 Otsuka Pharmaceutical Co.,Ltd. 1 JXHL2500152 Centanafadine持释胶囊 Otsuka Pharmaceutical Co.,Ltd. 1 JXHL2500151 Centanafadine持释胶囊 Otsuka Pharmaceutical Co.,Ltd. 1 JXHL2500150 BI 907828片 Boehringer Ingelheim International GmbH 1 JXHL2500147 BI 907828片 Boehringer Ingelheim International GmbH 1 JXHL2500146 BI 907828片 Boehringer Ingelheim International GmbH 1 JXHL2500145 Quabodepistat片 Otsuka Pharmaceutical Co., Ltd. 1 JXHL2500130 PF-08046054 (注射用冻干粉针) Pfizer Inc. 1 JXSL2500111 U3-1402 Daiichi Sankyo, Inc. 1 JXSL2500112 AZD8205 AstraZeneca AB 1 JXSL2500103 AZD6621 AstraZeneca AB 1 JXSL2500090 DS-1062a Daiichi Sankyo, Inc. 2.2 JXSL2500102 中药相关申请 药品名称 企业 注册分类 受理号 通窍静眩颗粒 九华华源药业股份有限公司 1.1 CXZL2500040 参乌胶囊 华北制药河北华诺有限公司 6.1 CXZS1700005冀;CXZS1700005 注：橙色字体部分结论为不批准或收到通知件；

Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled Treatment-Naïve, or Almost Naïve, Patients with DME Results presented by Michael A. Singer, M.D. in a paper-on-demand presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting Conference call scheduled for today at 8:30 am ET July 23, 2025 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macular edema (DME). The results were presented in a paper-on-demand presentation by Michael A. Singer, M.D., Clinical Professor of Ophthalmology at University of Texas Health Science Center and Director of Clinical Research at Medical Center Ophthalmology Associates in Texas, for the American Society of Retina Specialists (ASRS) Annual Scientific Meeting. The primary endpoint of the trial was the mean total number of supplemental aflibercept injections needed for the treatment of DME in the ILUVIEN arm compared to the aflibercept arm over the 18-month study period in the intent-to-treat (ITT) population. Patients were randomized to an induction phase to receive either a single ILUVIEN injection or a series of 5 monthly injections of aflibercept, followed by supplemental aflibercept injections as needed. Treatment with ILUVIEN (n=154) demonstrated a numerical reduction in the mean number of supplemental aflibercept injections compared to the aflibercept arm (n=152) but did not reach the threshold for statistical significance (2.4 vs. 2.5; p=0.756), and therefore the primary endpoint was not met. The secondary endpoint of mean time from last treatment injection to first supplemental aflibercept injection was met with a mean time of 185.4 days in the ILUVIEN arm (n=154), compared to 132.8 days in the aflibercept arm (n=152) (p A post-hoc analysis was conducted on a subset of randomized patients without major protocol deviations—such as being enrolled or randomized despite not meeting eligibility criteria, receiving incorrect treatment, or being administered prohibited concomitant medications or therapies. In this Post-Hoc Patient (PP) Population, the ILUVIEN arm (n=128) demonstrated a statistically significant difference in the mean number of supplemental aflibercept injections compared to the aflibercept arm (n=134), with 1.8 vs. 2.5 injections, respectively (p=0.029). Patients randomized to the ILUVIEN arm therefore received a single ILUVIEN injection and a mean of 1.8 supplemental injections, for a total of 2.8 injections, compared to patients in the aflibercept arm, who received 5 initial aflibercept injections and a mean of 2.5 supplemental injections, for a total of 7.5 injections. “Research suggests that DME is a multifactorial disease driven not only by increased production of VEGF, but also chronic inflammation,” said Dr. Singer. “The NEW DAY study provides clinically meaningful data on ILUVIEN’s potential impact on treatment burden, including a statistically significant difference in time to first supplemental injection of aflibercept in the ILUVIEN arm compared to the aflibercept arm. This potential reduction in treatment burden can be critical for our patients with diabetic macular edema as their disease is multifactorial, necessitating multiple visits to medical specialists.” ILUVIEN is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. In addition, secondary endpoints that assessed visual acuity and anatomic changes in the ITT population demonstrated non-inferiority between the ILUVIEN arm and the aflibercept arm. The mean change from baseline in best corrected visual acuity (BCVA) score over 18 months in patients who did not meet the prespecified non-inferiority margin of 4 ETDRS (Early Treatment Diabetic Retinopathy Study) letters was 1.8 in the ILUVIEN arm (n=154) versus 5.5 in the aflibercept arm (n=152) (p=0.080 at month 18). The mean change from baseline in central subfield thickness (CST) over 18 months in the ILUVIEN arm was -118.8 compared to -113.6 in the aflibercept arm (p=0.709 at month 18). Additional secondary endpoints will be further evaluated. “ILUVIEN is already an established treatment option for diabetic macular edema and the results of the NEW DAY trial further highlight its potential as an important option for patients impacted by this disease,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. “We believe these data have the potential to support earlier usage of ILUVIEN as part of its role in reducing treatment burden in DME. We are pleased to share the results at the ASRS meeting and look forward to presenting additional data in the future to further inform clinical decision-making.” For safety, ILUVIEN was well tolerated in the trial, with a safety profile that is consistent with data from prior ILUVIEN clinical trials and real-world use. In the ITT patient population, 41 percent of patients in the ILUVIEN arm experienced treatment-related treatment-emergent adverse events (mainly associated with cataract/subcapsular cataract (n=50) and increase in intraocular pressure (IOP) (n=24)), compared to 3 percent in the aflibercept arm. Serious treatment-related treatment-emergent adverse events were not seen in either arm. Sixteen percent of patients in the ILUVIEN arm experienced an increase in IOP compared to 3 percent in the aflibercept arm. In the ILUVIEN arm, 11 percent of patients experienced an increase in IOP of ≥25 mmHg compared to 3 percent in the aflibercept arm. In the ILUVIEN arm, 4.5 percent of patients required any laser or incisional IOP-lowering intervention during the study compared to 1.3 percent in the aflibercept arm. NEW DAY is a prospective, multicenter, masked, randomized, active-controlled trial that enrolled 306 eyes of treatment-naïve, or almost naïve, DME patients at approximately 42 sites around the U.S. To be enrolled in the study, patients had to be ≥18 years old with a diagnosis of Type 1 or Type 2 diabetes with center-involving DME confirmed by SD-OCT and CST of ≥ 350µm and best corrected visual acuity (BCVA) of ≥35 ETDRS Letters and ≤80 ETDRS letters in the study eye at the screening visit. Patients were excluded from the study if, among other things, they had received the following in the study eye: intravitreal or periocular steroids, intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to screening visit; > 1 intravitreal injection of ranibizumab or bevacizumab in the last 12 months; or had received ranibizumab or bevacizumab ≤ 6 weeks prior to the screening visit. Patients were also screened with a steroid challenge of difluprednate QID for 2 weeks. Patients who were determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from the screening visit were excluded. Patients were randomized to either an ILUVIEN arm or an aflibercept arm. Patients in the ILUVIEN arm received an ILUVIEN intravitreal implant while patients in the aflibercept arm received five injections of anti-VEGF therapy (intravitreal aflibercept 2 mg) at four-week intervals for the first 16 weeks of the trial during an induction period. After the 16-week induction period, patients in both arms were evaluated every four weeks during a 13-month maintenance period and received supplemental aflibercept injections only as needed. The criteria for supplemental treatment was set by identical protocol in both arms. Patients in the ILUVIEN arm were also permitted to receive supplemental aflibercept injections during the induction period if needed by protocol criteria following the injection of ILUVIEN. During the maintenance period, patients in the aflibercept arm only received supplemental aflibercept injections if needed per protocol definition. The recommended dosing in the prescribing information for aflibercept is an injection once every 8 weeks following an injection every 4 weeks for the first 5 injections. The primary endpoint of the study was the mean number of supplemental aflibercept injections needed for the treatment of DME in the study eye during the study in the ITT population. Diabetic macular edema (DME) occurs when blood vessels leak into a part of the retina called the macula, causing swelling that can lead to blurry vision and vision loss. Over time, about 7% of people with diabetes will develop DME, and approximately 4% will develop clinically significant macular edema, which causes blurred vision in the early stage and may cause cumulative damage over the long term. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. 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