2012年至今根据BPCA开展的小儿研究评审和根据PREA开展的小儿评估综述
正文 · 中文译文
2012年至今根据BPCA开展的小儿研究评审和根据PREA开展的小儿评估评审 开发资源 推进真实世界证据计划 抗菌药物开发工作组 BEST资源分类体系 临床结局评估汇编 复杂创新试验设计会议计划 FDA认可的抗微生物药敏感性试验解释标准 医学影像与药物开发 模型引导的药物开发配对会议计划 新药办公室定制医学查询（OCMQs） 儿科与孕产妇健康 罕见病终点推进试点计划 拆分实时申请审评（STAR） 标准安全性表格和图形（ST&Fs） 药物和生物制品开发替代终点资源 药物相互作用与标签 标签信息 | 药品 根据《联邦食品、药品和化妆品法案》第505A(k)(1)条和第505B(h)(1)条（分别为BPCA和PREA）的要求，以下是根据《最佳儿童药品法案》（BPCA）签发的书面请求所开展的小儿研究的医学、统计学和临床药理学评审，以及根据PREA开展的小儿评估。 根据BPCA研究的 products 总数 = 104 根据PREA评估的 products 总数 = 598 根据两者研究或评估的 products 总数 = 84 查找2002至2007年根据BPCA开展的小儿研究评审 查找生物制品PREA评审和标签变更 A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z 药物申办方 | 申办方 | 医学审评 | 临床药理学审评 | 统计学审评 | BPCA或PREA或两者兼有 Abametapir - Xeglyze | Hatchtech Pty Ltd | 医学（PDF - 4 MB） 增补（PDF - 78 KB） CDTL（PDF - 3 MB） 临床药理学（PDF - 6 MB） | 统计学（PDF - 207 KB） | PREA 阿巴卡韦和拉米夫定 - Epzicom | ViiV Healthcare Company | 医学（PDF - 3 MB） | 临床药理学（PDF - 158 KB） | 统计学（PDF - 693 KB） | PREA 阿巴卡韦和拉米夫定 - 无 | Mylan Laboratories Limited（Viatris旗下公司） | 医学（PDF - 211 KB） | 无 | 无 | PREA 阿巴卡韦、多替拉韦和拉米夫定 - Triumeq | ViiV Healthcare Company | 医学（PDF - 443 KB） | 临床药理学（PDF - 128 KB） | 无 | PREA 阿巴卡韦、多替拉韦和拉米夫定 - Triumeq ViiV Healthcare Company c/o GlaxoSmithKline | 医学（PDF - 389 KB） CDTL（PDF - 798 KB） 临床药理学（PDF - 128 KB） | 无 | PREA 阿巴卡韦、多替拉韦和拉米夫定 - Triumeq PD | ViiV Healthcare Company | CDTL（PDF - 758 KB） | 临床药理学（PDF - 3 MB） | 无 | 两者兼有 硫酸阿巴卡韦 - Ziagen | ViiV Healthcare Company | 医学（PDF - 4 MB） | 临床药理学（PDF - 3 MB） | 统计学（PDF - 5 MB） | PREA 阿巴西普 - Orencia | Bristol-Myers Squibb Company | 医学（PDF - 259 KB） 医学增补（PDF - 469 KB） 临床药理学（PDF - 2 MB） 临床药理学（PDF - 269 KB） 无 | 两者兼有 阿巴西普 - Orencia | Bristol-Myers Squibb Company | 医学（PDF - 4 MB） | 无 | 无 | BPCA 肉毒杆菌毒素A（AbobotulinumtoxinA） - Dysport | Ipsen Bipharm Limited | CDTL审评（PDF - 2 MB） 医学（PDF - 3 MB）无统计学（PDF - 2 MB）PREA 阿巴西普 - DysportIpsen Bipharm Limited医学（PDF - 1 MB）无统计学（PDF - 857 KB）PREA 阿布昔替尼 - Cibinqo 辉瑞公司医学（PDF - 10 MB）无无PREA 阿布昔替尼 - Cibinqo辉瑞公司医学（PDF - 5 MB）无无PREA 对乙酰氨基酚 - OfirmevMallInc.krodt, Inc.医学（PDF - 1 MB）临床药理学（PDF - 5 MB）统计学（PDF - 378 KB）两者 乙酰半胱氨酸 - LegubetiGalephar Pharmaceutical Research Inc.统一审评（PDF - 6 MB） 统一审评CR（PDF - 10 MB） 无无PREA 阿昔洛韦5%，氢化可的松1% - Xerese Valeant International Bermuda医学（PDF - 885 KB）无无PREA 阿达木单抗-adaz - Hyrimoz 山德士公司医学（PDF - 2 MB） CDTL审评（PDF - 300 MB） 无无PREA 阿达木单抗-adaz - Hyrimoz山德士公司CDTL审评（PDF - 342 KB）无无PREA 阿达木单抗-adaz - Hyrimoz山德士公司CDTL审评（PDF - 34 KB）无无PREA 阿达木单抗-afzb - Abrilada 辉瑞公司CDTL（PDF - 34 KB）无无PREA 阿达木单抗-afzb - Abrilada 辉瑞公司医学（PDF - 1 MB）无无PREA 阿达木单抗-afzb - Abrilada辉瑞公司CDTL（PDF - 34 KB）无无PREA 阿达木单抗-aqvh - Yusimry Coherus BioSciences, Inc医学（PDF - 5 MB）无无PREA 阿达木单抗-aqvh - YusimryCoherus BioSciences, IncCDTL审评（PDF - 342 KB）临床药理学（PDF - 22 KB）无PREA 阿达木单抗-aaty - YuflymaCelltrion, Inc.CDTL审评（PDF - 342 KB）无无PREA 阿达木单抗-atto - AmjevitaAmgen Inc.CDTL审评（PDF - 4 MB） 医学（PDF - 199K KB） 医学（PDF - 336KB） DD 摘要审评（PDF - 3 MB）临床药理学（PDF - 3 MB）统计学（PDF - 416 KB） 统计学（PDF - 363 KB） 统计学（PDF - 717 KB）PREA 阿达木单抗-aaty - YuflymaCelltrion, Inc.CDTL - DD（PDF - 356 KB）临床药理学（PDF - 2 MB）无PREA 阿达木单抗-atto - AmjevitaAmgen, IncCDTL（PDF - 580 KB）无无PREA 阿达木单抗-atto - AmjevitaAmgen, Inc医学（PDF - 532 KB）无无PREA 阿达木单抗-atto - Amjevita Amgen, Inc医学（PDF - 532 KB）无无PREA 阿达木单抗-bwwd - HadlimaSamsung Bioepis Co., Ltd.医学（PDF - 34 KB）临床药理学（PDF - 1 MB）无PREA 阿达木单抗-bwwd - HadlimaSamsung Bioepis Co., Ltd.医学（PDF - 34 KB）无无PREA 阿达木单抗-fkjp - HulioMylan Pharmaceuticals Inc.医学（PDF - 2 MB）无无PREA 阿达木单抗-fkjp - Hulio Mylan Pharmaceuticals Inc.医学（PDF - 580 KB）无无PREA 阿达木单抗-fkjp - HulioMylan Pharmaceuticals Inc.CDTL（PDF - 24 KB）无无PREA 阿达木单抗 - HumiraAbbVie,Inc.医学（PDF - 2 MB）无无PREA 阿达木单抗-aacf - IdacioFresenius Kabi USA, LLC医学（PDF - 20 MB）无无PREA 阿达木单抗-ryvk - SimlandiAlvotech USA Inc医学（PDF - 724 KB）无无PREA 阿达帕林和过氧化苯甲酰 - EpiduoGalderma Laboratories, LP医学（PDF - 2 MB）临床药理学（PDF -124 KB）统计学（PDF - 577 KB）PREA 阿达帕林和过氧化苯甲酰 - Epiduo ForteGalderma Research and Development LLC医学（PDF - 6.2 MB）临床药理学（PDF - 4 MB）统计学（PDF - 2 MB）PREA 阿法替尼 - GilotrifBoehringer Ingelheim Pharmaceuticals, Inc.医学（PDF - 5 MB）无无BPCA 阿柏西普-博阿夫 - EydenzeltCELLTRION, Inc.CDTL1（PDF - 1 MB） CDTL2（PDF - 3 MB） CDTL3（PDF - 976 KB） 无无PREA 阿柏西普 - Eylea Regeneron Pharmaceuticals, Inc.医学（PDF - 1 MB）临床药理学（PDF - 2 MB）统计学（PDF - 5 MB）BPCA 阿尼芬净 - EraxisVicuron Holdings LLC，Pfizer Inc.的子公司医学（PDF - 5 MB）无无PREA 沙丁胺醇和布地奈德 - Airsupra Bond Avillion 2 Development LP医学（PDF - 12 MB）无无PREA 硫酸沙丁胺醇 - ProAir RespiClickTeva Pharmaceutical Products R. & D., Inc.医学（PDF - 3 MB）临床药理学（PDF - 4 MB）统计学（PDF - 2 MB）PREA 硫酸沙丁胺醇 - ProAir RespiClick Teva Branded Pharmaceutical Products R&D, Inc.医学（PDF - 859 KB）临床药理学（PDF - 3 MB）统计学（PDF - 1 MB）PREA 阿利西尤单抗 - PraluentRegeneron Pharmaceuticals, Inc医学（PDF - 859 KB）临床药理学（PDF - 3 MB）统计学（PDF - 1 MB）PREA 阿利吉仑 - TekturnaNoden Pharma DACCDTL（PDF - 310 KB）临床药理学（PDF - 3 MB）统计学（PDF - 442 KB）BOTH 阿格列汀 - NesinaTakeda Pharmaceuticals U.S.A., Inc医学（PDF - 6 MB）临床药理学（PDF - 937 KB）统计学（PDF - 536 KB）PREA 阿格列汀和二甲双胍 - KazanoTakeda Pharmaceuticals U.S.A., Inc.医学（PDF - 6 MB）临床药理学（PDF - 937 KB）统计学（PDF - 536 KB）PREA 苯甲酸氨氯地平 - KaterziaSilvergate Pharmaceuticals, Inc医学（PDF - 46 KB）临床药理学（PDF - 337 KB）无PREA 氨氯地平 - NorliqvaCMP Development LLC医学（PDF - 21 KB）临床药理学（PDF - 683 KB） 氨氯地平 - SdamloBrillian Pharma Inc.CDTL - DD（PDF - 578 KB）临床药理学（PDF - 2 MB）无PREA 安非他明 - Adzenys ERNeos Therapeutics, Inc.医学（PDF - 2 MB）临床药理学（PDF - 4 KB）无PREA 安非他明缓释口崩片 - Adzenys XR-ODT Neos Therapeutics, Inc.医学（PDF - 470 KB）临床药理学（PDF - 3 MB）无PREA 安非他明 - Dyanavel XRTris Pharma医学（PDF - 2 MB）临床药理学（PDF - 5 MB）统计学（PDF - 767 KB）PREA 安非他明 - Dyanavel XRTris Pharma医学（PDF - 848 KB） CDTL审评（PDF - 1 MB） 无无 PREA 硫酸安非他明 - EvekeoArbor Pharmaceuticals, LLC医学（PDF - 1 MB） 医学（PDF - 155 KB） 临床药理学（PDF - 9 KB） 临床药理学备忘录（PDF - 9 KB） 统计学（PDF - 532 KB）PREA 阿哌沙班 - Eliquis Bristol-Myers Squibb Company医学（PDF - 6 MB）无无PREA 阿普司特 - OtezlaAmgen, Inc医学（PDF - 7 MB）无无BOTH 阿普司特 - OtezlaAmgen, Inc医学（PDF - 7 MB）无无PREA 阿瑞匹坦 - EmendMerck Sharp & Dohme Corp.医学（PDF - 6 MB） 医学补充（PDF - 1 MB） 医学DD备忘录（PDF - 3 MB）临床药理学（PDF - 5 MB） 临床药理学补充（PDF - 424 KB）统计学（PDF - 1 MB）PREA 阿瑞匹坦 - EmendMerck Sharp & Dohme Corp.医学（PDF - 553 KB）临床药理学（PDF - 5 MB） 补充（PDF -105 KB）统计学（PDF - 1 MB）PREA 阿立哌唑 - AbilifyOtsuka医学（PDF - 2 MB）无统计学（PDF - 409 KB）PREA 阿立哌唑 - MezofyCMG Pharmaceutical Co., LtdCDTL（PDF - 251 KB） 医学（PDF - 1 MB） 无无PREA 阿立哌唑 - Opipza 厦门力品药业有限公司 医学（PDF - 2 MB）无 无 PREA 阿替卡因眼科溶液 - Cyklx American Genomics, LLC 医学（PDF - 453 KB） CDTL-DD（PDF - 1 MB） 临床药理学（PDF - 519 KB）统计学（PDF - 767 KB）PREA 阿塞那平 - Saphris Forest Laboratories, Inc. 医学（PDF - 5 MB） 医学（PDF - 4 MB）临床药理学（PDF - 4 MB）统计学（PDF - 3 MB）两者 天冬酰胺酶欧文氏菌（重组）- rywn - Rylaze Jazz Pharmaceuticals Ireland Limited 医学（PDF - 4 MB）无 无 PREA 阿扎那韦和考比司他 - Evotaz 百时美施贵宝公司 CDTL（PDF - 402 KB）临床药理学（PDF - 1 MB）无 PREA 阿扎那韦 - Reyataz 百时美施贵宝公司 医学（PDF - 14 MB）临床药理学（PDF - 1 MB）统计学（PDF - 2 MB）两者 阿扎那韦 - Reyataz 百时美施贵宝公司 医学（PDF - 2 MB）临床药理学（PDF - 1 MB）统计学（PDF - 4 MB）两者 阿替利珠单抗 - TECENTRIQ Genentech, Inc. 医学（PDF - 1 MB）无 无 BPCA 阿替利珠单抗 - Tecentriq Genentech, Inc. 医学（PDF - 3 MB）无 无 BPCA 托莫西汀 - Atoncy MAP77 LLC 医学（PDF - 1 MB）无 无 PREA 阿托伐他汀钙 - Atorvaliq CMP Development LLC 医学（PDF - 3 MB）临床药理学（PDF - 1 MB）无 PREA 阿托品-解磷定 - DueDote Meridian Medical Technologies, Inc. CDTL（PDF - 402 KB） 医学（PDF - 886 KB） 临床药理学（PDF - 1 MB）无 PREA 硫酸阿托品 - Isopto Atropine 1% Alcon Research, Ltd. 医学（PDF - 663 KB）临床药理学（PDF - 480KB）统计学（PDF - 230 KB）PREA 硫酸阿托品滴眼液Akorn公司医学审评（PDF - 1 MB）临床药理学（PDF - 1 MB）统计学审评（PDF - 287 KB）PREA 阿昔替尼 - InlytaPF PRISM C.V.医学审评（PDF - 849 KB）临床药理学（PDF - 2 MB）无两者均有 盐酸氮卓斯汀 - AsteproMeda制药临床审评（PDF - 1 MB）无统计学审评（PDF - 473 KB）PREA 盐酸氮卓斯汀 - AsteproMeda制药公司医学审评（PDF - 2 MB）无无两者均有 盐酸氮卓斯汀和丙酸氟替卡松 - DymistaMeda制药公司医学审评（PDF - 3 MB）无统计学审评（PDF - 2 MB）两者均有 巴氯芬 - FleqsuvyAzurity制药公司医学审评（PDF - 2 MB）临床药理学（PDF - 367 KB）无PREA 巴氯芬 - LyvispahSaol治疗研究有限公司医学审评（PDF - 2 MB）临床药理学（PDF - 448 KB）无PREA 玛巴洛沙韦 - Xofluza盐野义株式会社 CDTL（PDF - 869 KB） 医学审评（PDF - 414 KB） 临床药理学（PDF - 3 MB）统计学审评（PDF - 2 MB） PREA 玛巴洛沙韦 - Xofluza基因泰克公司CDTL（PDF - 853 KB） 医学审评（PDF - 6 MB KB） 临床药理学（PDF - 420 KB）无PREA 玛巴洛沙韦 - Xofluza基因泰克公司医学审评（PDF - 248 KB）无无PREA 硫酸钡 - E-Z-DISKBracco诊断公司医学审评（PDF - 12 KB） DD摘要审评（PDF - 233 57 KB） 无无PREA 硫酸钡 - E-Z-HD Bracco诊断公司医学审评（PDF - 2 MB）临床药理学（PDF -642KB）统计学审评（PDF -988KB）PREA 硫酸钡 - READI-CAT 2 与 READI-CAT 2 SMOOTHIE Bracco DiagnosticsMedical（PDF - 2 MB）临床药理学（PDF - 702 KB）统计学（PDF -1 MB）PREA 硫酸钡 - Varibar PuddingBracco Diagnostics, Inc.医学（PDF - 1 MB）无无 PREA 硫酸钡 - Liquid E-Z-PaqueBracco Diagnostics, Inc.DD 摘要审评（PDF - 233 KB）无无PREA 二丙酸倍氯米松 - QnaslTeva Branded Pharmaceutical Products R&D, Inc.医学（PDF - 4 MB）临床药理学（PDF - 2 MB）统计学（PDF -959 KB）PREA 贝利尤单抗 - BenlystaGlaxoSmithKline（GSK）LLC医学（PDF - 5 MB）无无PREA Belumosudil - Rezurock Kadmon Pharmaceuticals, LLC医学（PDF - 7 MB）无无PREA 贝利尤单抗 - Benlysta Human Genome Sciences医学（PDF - 6 MB）无无PREA 贝利尤单抗 - BenlystaGlaxoSmithKline LLC医学（PDF - 7 MB）无无PREA Belzutifan - WeliregMerck Sharpe & Dohme LLC医学（PDF - 12 MB）无无PREA 贝那利珠单抗 - FasenraAstraZeneca AB医学（PDF - 2 MB）临床药理学（PDF - 7 MB）统计学（PDF - 2 MB）PREA 贝那利珠单抗 - FasenraAstraZeneca AB c/o AstraZeneca Pharmaceuticals LP医学（PDF - 7 MB） Unireview（PDF - 11 KB） 无无PREA Berdazimer - ZelsuvmiLNHC, Inc.医学（PDF - 12 MB）无无PREA Berotralstat - OrladeyoBioCryst Pharmaceuticals, Inc.医学（PDF - 7 MB）无无PREA Bezlotoxumab - Zinplava Merck Sharp & Dohme Corp.医学（PDF - 2 MB）无无BOTH 比克替拉韦、恩曲他滨和丙酚替诺福韦 - Biktarvy Gilead Sciences, Inc.CDTL（PDF - 157 KB） CDTL 1（PDF - 2 MB） 临床药理学（PDF - 2 MB）无BOTH 比克替拉韦、恩曲他滨和替诺福韦艾拉酚胺 - BiktarvyGilead Sciences, Inc. CDTL（PDF - 2 MB）临床药理学（PDF - 4 MB）无两者 比马前列素滴眼液，0.03% - LatisseAllergan, Inc.DD摘要审评（PDF - 966KB） CDTL审评（PDF - 3 MB） 医学（PDF - 2 MB）无统计学（PDF -946KB） 统计学增补（PDF - 127KB）PREA 贝林妥欧单抗 - Blincyto Amgen, Inc.医学（PDF - 3 MB）临床药理学（PDF -1 MB）统计学（PDF - 374 KB）BPCA 贝林妥欧单抗 - BlincytoAmgen, Inc.医学（PDF - 9 MB）无无BPCA 硼替佐米 - VelcadeMillennium Pharmaceuticals, Inc.医学（PDF - 4 MB）临床药理学（PDF - 1 MB）统计学（PDF - 374 KB）BPCA 博舒替尼 - BOSULIFPF Prism C.V医学（PDF - 10 MB）无无BPCA 布地奈德 - Entocort ECElan Pharma International医学（PDF - 3 MB）临床药理学（PDF - 3 MB）统计学（PDF - 1 MB）PREA 布伦索卡替布 - BrinsupriInsmed Incorporated医学（PDF - 21 MB）无无PREA 维布妥昔单抗 - AdcetrisSeagen Inc.医学（PDF - 1 MB）无无BPCA 布瑞诺龙 - ZulressoSage Therapeutics, Inc.医学（PDF - 1 MB）无无PREA 依匹哌唑 - Rexulti Otsuka Pharmaceutical Company, Ltd.医学（PDF - 4 MB）无无PREA 依匹哌唑 - Rexulti Otsuka Pharmaceutical Company, Ltd. C/O Otsuka Pharmaceutical Development & Commercialization, Inc.医学（PDF - 3 MB）无无BPCA 依匹哌唑 - RexultiOtsuka Pharmaceutical Company Ltd.医学（PDF - 3 MB）无无PREA 酒石酸溴莫尼定 - LumifyBausch + LombCDTL审评（PDF - 3 MB） 医学（PDF - 556 KB）临床药理学（PDF - 51 KB）统计学（PDF - 219 KB）PREA 布瓦西坦 - Briviact UCB公司CDTL审评（PDF - 297 KB） 医学（PDF - 1 MB） 临床药理学（PDF - 2 MB）无PREA 布瓦西坦 - Briviact UCB公司医学（PDF - 74 KB）临床药理学（PDF - 2 MB）无PREA 布地奈德/富马酸福莫特罗二水合物 - SymbicortAstraZeneca制药公司医学（PDF - 3 MB）临床药理学（PDF - 1 MB）统计学（PDF - 3 MB）两者 布地奈德和富马酸福莫特罗 - Symbicort AerosphereAstraZeneca制药公司医学（PDF - 6 MB）无无PREA 布比卡因 - ExparelPacira制药公司医学（PDF - 6 MB）临床药理学（PDF - 2 MB）无PREA 丁丙诺啡 - ButransPurdue Pharma L.P.医学（PDF - 4 MB）临床药理学（PDF - 2 MB）无PREA 卡巴他赛 - JevtanaSanofi-Aventis U.S., L.L.C.医学（PDF - 2 MB）临床药理学（PDF - 1 MB）无BPCA 卡博特韦 - ApretudeViiV Healthcare公司医学（PDF - 8 MB）无无PREA 卡博特韦 - ApretudeViiV Healthcare公司医学（PDF - 8 MB）临床药理学（PDF - 1 MB）无PREA 卡博特韦-利匹韦林 - Cabenuva ViiV Healthcare公司医学（PDF - 35 KB）临床药理学（PDF - 1 MB） 临床药理学附录（PDF - 229 KB） 无PREA 卡博特韦和利匹韦林 - CabenuvaViiV Healthcare公司医学（PDF - 525 KB）临床药理学（PDF - 5 MB）无PREA 卡博特韦 - VocabriaViiV Healthcare公司CDTL（PDF - 1 MB） 医学（PDF - 525 KB） 临床药理学（PDF - 2 MB） 附录（PDF - 115 KB） 无PREA 卡博特韦 - VocabriaViiV 医疗公司医学审评（PDF - 525 KB）临床药理学（PDF - 5 MB）无PREA 卡博替尼 - CabometyxExelixis 公司医学审评（PDF - 9 MB）无无PREA 卡泊三烯 - SORILUXMayne Pharma LLC医学审评（PDF - 525 KB）临床药理学（PDF - 1 MB）无PREA 卡泊三烯与二丙酸倍他米松 - TaclonexLEO Pharma A/S医学审评（PDF -6 MB）临床药理学（PDF - 2 MB）统计学审评（PDF - 564 KB）PREA 卡泊三烯与二丙酸倍他米松 - TaclonexLEO Pharma A/S c/o LEO Pharma, Inc.医学审评（PDF - 4 MB）临床药理学（PDF - 3 MB）无PREA 卡泊三烯与二丙酸倍他米松 - TaclonexLEO Pharma A/S医学审评（PDF - 775 KB）临床药理学（PDF - 528 KB）无PREA 卡泊三烯与倍他米松 - EnstilarLEO Pharma A/S医学审评（PDF - 1 MB）临床药理学（PDF - 458 KB）无BOTH 葡萄糖酸钙注射液 - 葡萄糖酸钙注射液Fresenius Kabi USA, LLC医学审评（PDF - 4 MB） 医学 CTDL（PDF - 2 MB） Cl
正文 · 英文原文
Reviews of Pediatric Studies Conducted under BPCA and Pediatric Assessments Conducted Under PREA from 2012 – Present Development Resources Advancing Real-World Evidence Program Antibacterial Drug Development Task Force BEST Resource Taxonomy Clinical Outcome Assessment Compendium Complex Innovative Trial Design Meeting Program FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria Medical Imaging and Drug Development Model-Informed Drug Development Paired Meeting Program Office of New Drugs Custom Medical Queries (OCMQs) Pediatrics and Maternal Health Rare Disease Endpoint Advancement Pilot Program Split Real Time Application Review (STAR) Standard Safety Tables and Figures (ST&Fs) Surrogate Endpoint Resources for Drug and Biologic Development Drug Interactions & Labeling Labeling Information | Drug Products As required by 505A(k)(1) and 505B(h)(1) of the Federal Food, Drug, & Cosmetic Act (BPCA and PREA, respectively), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the Best Pharmaceuticals for Children Act (BPCA) and pediatric assessments conducted under PREA. Total Number of Products Studied under BPCA = 104 Total Number of Products assessed under PREA = 598 Total Number of Products Studied or assessed under Both = 84 Find Reviews of Pediatric Studies Conducted under BPCA from 2002 – 2007 Find Biologics PREA Reviews and Labeling Changes A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z Drug SponsorSponsorMedical ReviewClinical Pharmacology ReviewStatistical ReviewBPCA or PREA or Both Abametapir - XeglyzeHatchtech Pty LtdMedical (PDF - 4 MB) Addendum (PDF - 78 KB) CDTL (PDF - 3 MB) Clinical pharmacology (PDF - 6 MB)Statistical (PDF - 207 KB)PREA Abacavir and Lamivudine - EpzicomViiV Healthcare CompanyMedical (PDF - 3 MB)Clinical pharmacology (PDF - 158 KB)Statistical (PDF - 693 KB)PREA Abacavir and lamivudine - NoneMylan Laboratories Limited, a Viatris CompanyMedical (PDF - 211 KB)NoneNonePREA Abacavir, Dolutegravir, and Lamivudine - TriumeqViiV Healthcare CompanyMedical (PDF - 443 KB)Clinical pharmacology (PDF - 128 KB)NonePREA Abacavir, Dolutegravir, and Lamivudine - Triumeq ViiV Healthcare Company c/o GlaxoSmithKlineMedical (PDF - 389 KB) CDTL (PDF - 798 KB) Clinical pharmacology (PDF - 128 KB)NonePREA Abacavir, Dolutegravir, and Lamivudine - Triumeq PDViiV Healthcare CompanyCDTL (PDF - 758 KB)Clinical pharmacology (PDF - 3 MB)NoneBOTH Abacavir sulfate - ZiagenViiV Healthcare CompanyMedical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 5 MB)PREA Abatacept - OrenciaBristol-Myers Squibb CompanyMedical (PDF - 259 KB) Medical Addendum (PDF - 469 KB) Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 269 KB) NoneBOTH Abatacept - OrenciaBristol-Myers Squibb CompanyMedical (PDF - 4 MB)NoneNoneBPCA AbobotulinumtoxinA - DysportIpsen Bipharm LimitedCDTL Review (PDF - 2 MB) Medical (PDF - 3 MB)NoneStatistical (PDF - 2 MB)PREA AbobotulinumtoxinA - DysportIpsen Bipharm LimitedMedical (PDF - 1 MB)NoneStatistical (PDF - 857 KB)PREA Abrocitinib - Cibinqo Pfizer Inc.Medical (PDF - 10 MB)NoneNonePREA Abrocitinib - CibinqoPfizer Inc.Medical (PDF - 5 MB)NoneNonePREA Acetaminophen - OfirmevMallInc.krodt, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 378 KB)BOTH Acetylcysteine - LegubetiGalephar Pharmaceutical Research Inc.Unireview (PDF - 6 MB) Unireview CR (PDF - 10 MB) NoneNonePREA Acyclovir 5%, hydrocortisone 1% - Xerese Valeant International BermudaMedical (PDF - 885 KB)NoneNonePREA Adalimumab-adaz - Hyrimoz Sandoz Inc.Medical (PDF - 2 MB) CDTL Review (PDF - 300 MB) NoneNonePREA Adalimumab-adaz - HyrimozSandoz Inc.CDTL Review (PDF - 342 KB)NoneNonePREA Adalimumab-adaz - HyrimozSandoz Inc.CDTL Review (PDF - 34 KB)NoneNonePREA Adalimumab-afzb - Abrilada Pfizer Inc.CDTL (PDF - 34 KB)NoneNonePREA Adalimumab-afzb - Abrilada Pfizer Inc.Medical (PDF - 1 MB)NoneNonePREA Adalimumab-afzb - AbriladaPfizer Inc.CDTL (PDF - 34 KB)NoneNonePREA Adalimumab-aqvh - Yusimry Coherus BioSciences, IncMedical (PDF - 5 MB)NoneNonePREA Adalimumab-aqvh - YusimryCoherus BioSciences, IncCDTL Review (PDF - 342 KB)Clinical pharmacology (PDF - 22 KB)NonePREA adalimumab-aaty - YuflymaCelltrion, Inc.CDTL Review (PDF - 342 KB)NoneNonePREA Adalimumab-atto - AmjevitaAmgen Inc.CDTL Review (PDF - 4 MB) Medical (PDF - 199K KB) Medical (PDF - 336KB) DD Summary Review (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 416 KB) Statistical (PDF - 363 KB) Statistical (PDF - 717 KB) PREA Adalimumab-aaty - YuflymaCelltrion, Inc.CDTL - DD (PDF - 356 KB)Clinical pharmacology (PDF - 2 MB)NonePREA Adalimumab-atto - AmjevitaAmgen, IncCDTL (PDF - 580 KB)NoneNonePREA Adalimumab-atto - AmjevitaAmgen, IncMedical (PDF - 532 KB)NoneNonePREA Adalimumab-atto - Amjevita Amgen, IncMedical (PDF - 532 KB)NoneNonePREA Adalimumab-bwwd - HadlimaSamsung Bioepis Co., Ltd.Medical (PDF - 34 KB)Clinical pharmacology (PDF - 1 MB)NonePREA Adalimumab-bwwd - HadlimaSamsung Bioepis Co., Ltd.Medical (PDF - 34 KB)NoneNonePREA Adalimumab-fkjp - HulioMylan Pharmaceuticals Inc.Medical (PDF - 2 MB)NoneNonePREA Adalimumab-fkjp - Hulio Mylan Pharmaceuticals Inc.Medical (PDF - 580 KB)NoneNonePREA Adalimumab-fkjp - HulioMylan Pharmaceuticals Inc.CDTL (PDF - 24 KB)NoneNonePREA Adalimumab - HumiraAbbVie,Inc.Medical (PDF - 2 MB)NoneNonePREA Adalimumab-aacf - IdacioFresenius Kabi USA, LLCMedical (PDF - 20 MB)NoneNonePREA Adalimumab-ryvk - SimlandiAlvotech USA IncMedical (PDF - 724 KB)NoneNonePREA Adapalene and benzoyl peroxide - EpiduoGalderma Laboratories, LPMedical (PDF - 2 MB)Clinical pharmacology (PDF -124 KB)Statistical (PDF - 577 KB)PREA Adapalene and benzoyl peroxide - Epiduo ForteGalderma Research and Development LLCMedical (PDF - 6.2 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)PREA Afatini - GilotrifBoehringer Ingelheim Pharmaceuticals, Inc.Medical (PDF - 5 MB)NoneNoneBPCA Aflibercept-boav - EydenzeltCELLTRION, Inc.CDTL1 (PDF - 1 MB) CDTL2 (PDF - 3 MB) CDTL3 (PDF - 976 KB) NoneNonePREA Aflibercept - Eylea Regeneron Pharmaceuticals, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 5 MB)BPCA Anidulafungin - EraxisVicuron Holdings LLC, a subsidiary of Pfizer Inc.Medical (PDF - 5 MB)NoneNonePREA Albuterol and Budesonide - Airsupra Bond Avillion 2 Development LPMedical (PDF - 12 MB)NoneNonePREA Albuterol sulfate - ProAir RespiClickTeva Pharmaceutical Products R. & D., Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 2 MB)PREA Albuterol sulfate - ProAir RespiClick Teva Branded Pharmaceutical Products R&D, Inc.Medical (PDF - 859 KB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREA Alirocumab - PraluentRegeneron Pharmaceuticals, IncMedical (PDF - 859 KB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREA Aliskiren - TekturnaNoden Pharma DACCDTL (PDF - 310 KB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 442 KB)BOTH Alogliptin - NesinaTakeda Pharmaceuticals U.S.A., IncMedical (PDF - 6 MB)Clinical pharmacology (PDF - 937 KB)Statistical (PDF - 536 KB)PREA Alogliptin and metformin - KazanoTakeda Pharmaceuticals U.S.A., Inc.Medical (PDF - 6 MB)Clinical pharmacology (PDF - 937 KB)Statistical (PDF - 536 KB)PREA Amlodipine benzoate - KaterziaSilvergate Pharmaceuticals, IncMedical (PDF - 46 KB)Clinical pharmacology (PDF - 337 KB)NonePREA Amlodipine - NorliqvaCMP Development LLCMedical (PDF - 21 KB)Clinical pharmacology (PDF - 683 KB) Amlodipine - SdamloBrillian Pharma Inc.CDTL - DD (PDF - 578 KB)Clinical pharmacology (PDF - 2 MB)NonePREA Amphetamine - Adzenys ERNeos Therapeutics, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 4 KB)NonePREA Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT Neos Therapeutics, Inc.Medical (PDF - 470 KB)Clinical pharmacology (PDF - 3 MB)NonePREA Amphetamine - Dyanavel XRTris PharmaMedical (PDF - 2 MB)Clinical pharmacology (PDF - 5 MB)Statistical (PDF - 767 KB)PREA Amphetamine - Dyanavel XRTris PharmaMedical (PDF - 848 KB) CDTL Review (PDF - 1 MB) NoneNone PREA Amphetamine sulfate - EvekeoArbor Pharmaceuticals, LLCMedical (PDF - 1 MB) Medical (PDF - 155 KB) Clinical pharmacology (PDF - 9 KB) Clinical pharmacology memo (PDF - 9 KB) Statistical (PDF - 532 KB)PREA Apixaban - Eliquis Bristol-Myers Squibb CompanyMedical (PDF - 6 MB)NoneNonePREA Apremilast - OtezlaAmgen, IncMedical (PDF - 7 MB)NoneNoneBOTH Apremilast - OtezlaAmgen, IncMedical (PDF - 7 MB)NoneNonePREA Aprepitant - EmendMerck Sharp & Dohme Corp.Medical (PDF - 6 MB) Medical Addendum (PDF - 1 MB) Medical DD memo (PDF - 3 MB)Clinical pharmacology (PDF - 5 MB) Clinical pharmacology addendum (PDF - 424 KB)Statistical (PDF - 1 MB)PREA Aprepitant - EmendMerck Sharp & Dohme Corp.Medical (PDF - 553 KB)Clinical pharmacology (PDF - 5 MB) Addendum (PDF -105 KB)Statistical (PDF - 1 MB)PREA Aripiprazole - AbilifyOtsukaMedical (PDF - 2 MB)NoneStatistical (PDF - 409 KB)PREA Aripiprazole - MezofyCMG Pharmaceutical Co., LtdCDTL (PDF - 251 KB) Medical (PDF - 1 MB) NoneNonePREA Aripiprazole - OpipzaXiamen LP Pharmaceutical Co., Ltd.Medical (PDF - 2 MB)NoneNonePREA Articaine ophthalmic solution - CyklxAmerican Genomics, LLCMedical (PDF - 453 KB) CDTL-DD (PDF - 1 MB) Clinical pharmacology (PDF - 519 KB)Statistical (PDF - 767 KB)PREA Asenapine - SaphrisForest Laboratories, Inc.Medical (PDF - 5 MB) Medical (PDF - 4 MB)Clinical pharmacology (PDF - 4 MB)Statistical (PDF - 3 MB)BOTH Asparaginase erwinia chrysanthemi (recombinant)- rywn - RylazeJazz Pharmaceuticals Ireland LimitedMedical (PDF - 4 MB)NoneNonePREA Atazanavir and cobicistat - EvotazBristol-Myers Squibb CompanyCDTL (PDF - 402 KB)Clinical pharmacology (PDF - 1 MB)NonePREA Atazanavir - ReyatazBristol-Myers Squibb CompanyMedical (PDF - 14 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 2 MB)BOTH Atazanavir - Reyataz Bristol-Myers Squibb CompanyMedical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 4 MB)BOTH Atezolizumab - TECENTRIQGenentech, Inc.Medical (PDF - 1 MB)NoneNoneBPCA Atezolizumab - TecentriqGenentech, Inc.Medical (PDF - 3 MB)NoneNoneBPCA Atomoxetine - Atoncy MAP77 LLCMedical (PDF - 1 MB)NoneNone PREA Atorvastatin calcium - AtorvaliqCMP Development LLCMedical (PDF - 3 MB)Clinical pharmacology (PDF - 1 MB)NonePREA Atropine-pralidoxime - DueDoteMeridian Medical Technologies, Inc.CDTL (PDF - 402 KB) Medical (PDF - 886 KB) Clinical pharmacology (PDF - 1 MB)NonePREA Atropine Sulfate - Isopto Atropine 1%Alcon Research, Ltd.Medical (PDF - 663 KB)Clinical pharmacology (PDF - 480KB)Statistical (PDF - 230 KB)PREA Atropine Sulfate Ophthalmic SolutionAkorn, Inc.Medical (PDF - 1 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 287 KB)PREA Axitinib - InlytaPF PRISM C.V.Medical (PDF - 849 KB)Clinical pharmacology (PDF - 2 MB)NoneBOTH Azelastine hydrochloride - AsteproMeda PharmaceuticalsClinical (PDF - 1 MB)NoneStatistical (PDF - 473 KBPREA Azelastine hydrochloride - AsteproMeda Pharmaceuticals Inc.Medical (PDF - 2 MB)NoneNoneBOTH Azelastine hydrochloride and Fluticasone propionate - DymistaMeda Pharmaceuticals, Inc.Medical (PDF - 3 MB)NoneStatistical (PDF - 2 MB)BOTH Baclofen - FleqsuvyAzurity Pharmaceuticals, Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 367 KB)NonePREA Baclofen - LyvispahSaol Therapeutics Research LimitedMedical (PDF - 2 MB)Clinical pharmacology (PDF - 448 KB)NonePREA Baloxavir marboxil - XofluzaShionogi, Incorporated CDTL (PDF - 869 KB) Medical (PDF - 414 KB) Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 2 MB) PREA Baloxavir marboxil - XofluzaGenentech, IncorporatedCDTL (PDF - 853 KB) Medical (PDF - 6 MB KB) Clinical pharmacology (PDF - 420 KB)NonePREA Baloxavir marboxil - XofluzaGenentech, IncorporatedMedical (PDF - 248 KB)NoneNonePREA Barium sulfate - E-Z-DISKBracco Diagnostics Inc.Medical (PDF - 12 KB) DD Summary Review (PDF - 233 57 KB) NoneNonePREA Barium sulfate - E-Z-HD Bracco Diagnostics Inc.Medical (PDF - 2 MB)Clinical pharmacology (PDF -642KB)Statistical (PDF -988KB)PREA Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE Bracco DiagnosticsMedical (PDF - 2 MB)Clinical pharmacology (PDF - 702 KB)Statistical (PDF -1 MB)PREA Barium sulfate - Varibar PuddingBracco Diagnostics, Inc.Medical (PDF - 1 MB)NoneNone PREA Barium sulfate - Liquid E-Z-PaqueBracco Diagnostics, Inc.DD Summary Review (PDF - 233 KB)NoneNonePREA Beclomethasone dipropionate - QnaslTeva Branded Pharmaceutical Products R&D, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF -959 KB)PREA Belimumab - BenlystaGlaxoSmithKline (GSK) LLCMedical (PDF - 5 MB)NoneNonePREA Belumosudil - Rezurock Kadmon Pharmaceuticals, LLCMedical (PDF - 7 MB)NoneNonePREA Belimumab - Benlysta Human Genome SciencesMedical (PDF - 6 MB)NoneNonePREA Belimumab - BenlystaGlaxoSmithKline LLCMedical (PDF - 7 MB)NoneNonePREA Belzutifan - WeliregMerck Sharpe & Dohme LLCMedical (PDF - 12 MB)NoneNonePREA Benralizumab - FasenraAstraZeneca ABMedical (PDF - 2 MB)Clinical pharmacology (PDF - 7 MB)Statistical (PDF - 2 MB)PREA Benralizumab - FasenraAstraZeneca AB c/o AstraZeneca Pharmaceuticals LPMedical (PDF - 7 MB) Unireview (PDF - 11 KB) NoneNonePREA Berdazimer - ZelsuvmiLNHC, Inc.Medical (PDF - 12 MB)NoneNonePREA Berotralstat - OrladeyoBioCryst Pharmaceuticals, Inc.Medical (PDF - 7 MB)NoneNonePREA Bezlotoxumab - Zinplava Merck Sharp & Dohme Corp.Medical (PDF - 2 MB)NoneNoneBOTH Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy Gilead Sciences, Inc.CDTL (PDF - 157 KB) CDTL 1 (PDF - 2 MB) Clinical pharmacology (PDF - 2 MB)NoneBOTH Bictegravir, emtricitabine, and tenofovir alafenamide - BiktarvyGilead Sciences, Inc. CDTL (PDF - 2 MB)Clinical pharmacology (PDF - 4 MB)NoneBOTH Bimatoprost ophthalmic solution, 0.03% - LatisseAllergan, Inc.DD Summary Review (PDF - 966KB) CDTL Review (PDF - 3 MB) Medical (PDF - 2 MB)NoneStatistical (PDF -946KB) Statistical Addendum (PDF - 127KB)PREA Blinatumomab - Blincyto Amgen, Inc.Medical (PDF - 3 MB)Clinical pharmacology (PDF -1 MB)Statistical (PDF - 374 KB)BPCA Blinatumomab - BlincytoAmgen, Inc.Medical (PDF - 9 MB)NoneNoneBPCA Bortezomib - VelcadeMillennium Pharmaceuticals, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 374 KB)BPCA Bosutinib - BOSULIFPF Prism C.VMedical (PDF - 10 MB)NoneNoneBPCA Budesonide - Entocort ECElan Pharma InternationalMedical (PDF - 3 MB)Clinical pharmacology (PDF - 3 MB)Statistical (PDF - 1 MB)PREA Brensocatib - BrinsupriInsmed IncorporatedMedical (PDF - 21 MB)NoneNonePREA Brentuximab vedotin - AdcetrisSeagen Inc.Medical (PDF - 1 MB)NoneNoneBPCA Brexanolone - ZulressoSage Therapeutics, Inc.Medical (PDF - 1 MB)NoneNonePREA Brexpiprazole - Rexulti Otsuka Pharmaceutical Company, Ltd.Medical (PDF - 4 MB)NoneNonePREA Brexpiprazole - Rexulti Otsuka Pharmaceutical Company, Ltd. C/O Otsuka Pharmaceutical Development & Commercialization, Inc.Medical (PDF - 3 MB)NoneNoneBPCA Brexpiprazole - RexultiOtsuka Pharmaceutical Company Ltd.Medical (PDF - 3 MB)NoneNonePREA Brimonidine tartrate - LumifyBausch + LombCDTL Review (PDF - 3 MB) Medical (PDF - 556 KB)Clinical pharmacology (PDF - 51 KB)Statistical (PDF - 219 KB)PREA Brivaracetam - Briviact UCB, Inc.CDTL Review (PDF - 297 KB) Medical (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB)NonePREA Brivaracetam - Briviact UCB, Inc.Medical (PDF - 74 KB)Clinical pharmacology (PDF - 2 MB)NonePREA Budesonide/formoterol fumarate dehydrate - SymbicortAstraZeneca Pharmaceuticals, LPMedical (PDF - 3 MB)Clinical pharmacology (PDF - 1 MB)Statistical (PDF - 3 MB)BOTH Budesonide and formoterol fumarate - Symbicort AerosphereAstraZeneca Pharmaceuticals LPMedical (PDF - 6 MB)NoneNonePREA Bupivacaine - ExparelPacira Pharmaceuticals, Inc.Medical (PDF - 6 MB)Clinical pharmacology (PDF - 2 MB)NonePREA Buprenorphine - ButransPurdue Pharma L.P.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 2 MB)NonePREA Cabazitaxel - JevtanaSanofi-Aventis U.S., L.L.C.Medical (PDF - 2 MB)Clinical pharmacology (PDF - 1 MB)NoneBPCA Cabotegravir - ApretudeViiV Healthcare CompanyMedical (PDF - 8 MB)NoneNonePREA Cabotegravir - ApretudeViiV Healthcare CompanyMedical (PDF - 8 MB)Clinical pharmacology (PDF - 1 MB)NonePREA Cabotegravir-rilpivirine - Cabenuva ViiV Healthcare CompanyMedical (PDF - 35 KB)Clinical pharmacology (PDF - 1 MB) Clinical pharmacology Addendum (PDF - 229 KB) NonePREA Cabotegravir and rilpivirine - CabenuvaViiV Healthcare CompanyMedical (PDF - 525 KB)Clinical pharmacology (PDF - 5 MB)NonePREA Cabotegravir - VocabriaViiV Healthcare CompanyCDTL (PDF - 1 MB) Medical (PDF - 525 KB) Clinical pharmacology (PDF - 2 MB) Addendum (PDF - 115 KB) NonePREA Cabotegravir - VocabriaViiV Healthcare CompanyMedical (PDF - 525 KB)Clinical pharmacology (PDF - 5 MB)NonePREA Cabozantinib - CabometyxExelixis, Inc.Medical (PDF - 9 MB)NoneNonePREA Calcipotriene - SORILUXMayne Pharma LLCMedical (PDF - 525 KB)Clinical pharmacology (PDF - 1 MB)NonePREA Calcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/SMedical (PDF -6 MB)Clinical pharmacology (PDF - 2 MB)Statistical (PDF - 564 KB)PREA Calcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/S c/o LEO Pharma, Inc.Medical (PDF - 4 MB)Clinical pharmacology (PDF - 3 MB)NonePREA Calcipotriene and Betamethasone dipropionate - TaclonexLEO Pharma A/SMedical (PDF - 775 KB)Clinical pharmacology (PDF - 528 KB)NonePREA Calcipotriene and betamethasone - EnstilarLEO Pharma A/SMedical (PDF - 1 MB)Clinical pharmacology (PDF - 458 KB)NoneBOTH Calcium Gluconate injection - Calcium Gluconate InjectionFresenius Kabi USA, LLCMedical (PDF - 4 MB) Medical CTDL (PDF - 2 MB) Cl