Atropine Sulfate

Company offers portfolio of treatment options and expert guidance following first confirmed case in the United States New World screwworm has officially reached the United States, with the first confirmed case in U.S. livestock in Texasi New World screwworm can infest any warm-blooded animals – including livestock and pets – posing a significant threat to animal health, welfare, and producer livelihood Elanco offers a portfolio of options for both livestock and pets that can treat infestations caused by New World screwworm larvae INDIANAPOLIS , June 4, 2026 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today reaffirms its commitment to providing veterinarians, livestock producers, and pet owners with resources and treatment options for their animals against the escalating threat posed by New World screwworm (NWS). The fly recently reached the United States, with the first case confirmed in U.S. livestock in Texas.i The emergence of New World screwworm in the U.S. creates a threat for veterinarians, livestock producers and pet owners that has not been seen north of the Florida Keys since the fly was eradicated from the United States more than 50 years ago.ii New World screwworm (Cochliomyia hominivorax) larvae feed on living tissue and can affect a wide range of warm-blooded animals, including livestock, companion animals, wildlife, and even humans.ii "New World screwworm could have a devastating impact on animal health, welfare, and producer livelihoods," said Jeff Simmons, President and CEO, Elanco Animal Health. "We want to thank the FDA, EPA and USDA, for all their work to prepare for this threat. We're committed to supporting our customers during this challenging time by delivering innovation, scientific expertise, and available resources to help treat New World screwworm and support the health and well-being of animals." With more than 70 years of animal health experience, including helping mitigate, prevent and treat New World screwworm in other parts of the world, Elanco is working alongside the U.S. animal health industry to help them fight against this parasite, offering a portfolio of options for pets and livestock that can help treat New World screwworm larvae infestations. Available Elanco Treatment and/or Prevention Options Negasunt Powder and Tanidil will be available only through the U.S. Animal Plant Health and Inspection Service (APHIS) and its National Veterinary Stockpile. They will be distributed in coordination with state animal health officials and federally recognized tribal agencies. In the near future, APHIS will share additional information about the requirements for use, including tracking and reporting requirements and required safety and personal protective equipment. As New World screwworm enters the United States, Elanco is committed to working alongside producers as they continuously evolve management practices and to help them implement prevention and treatment protocols to use the right product at the right time. To learn more about Elanco's ongoing efforts and historical perspective on New World screwworm, please visit our previous coverage: Elanco's Negasunt™ Powder (Coumaphos, Propoxur, Sulfanilamide Topical Powder) and Tanidil™ (Coumaphos, Propoxur) Receive Emergency Authorization for Use Against New World Screwworm in Livestock Elanco's Credelio Quattro™-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) Receives First FDA Conditional Approval for Treatment of New World Screwworm in Dogs Elanco's Credelio™ CAT (lotilaner) Receives First FDA Emergency Use Authorization (EUA) for Treatment of New World Screwworm (NWS) in Cats Elanco's Credelio™ (lotilaner) Receives First Ever FDA Emergency Use Authorization (EUA) against New World Screwworm (NWS) in Dogs To learn more about New World screwworm (NWS) using the following resources: USDA NWS Alert and Fact Sheet NCBA NWS Resources FDA Information for Veterinarians on NWS About Elanco Animal Health Elanco Animal Health Incorporated is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. Learn more at . Indications for Credelio Quattro/Credelio Quattro-CA1 Credelio Quattro is indicated for the prevention of heartworm disease and the treatment and control of roundworm, hookworm, and tapeworm infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations and the treatment and control of tick infestations for 1 month in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater. Credelio Quattro is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks. Credelio Quattro-CA1 is conditionally approved for the treatment of infestations caused by New World screwworm (NWS) larvae in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater. Important Safety Information for Credelio Quattro/Credelio Quattro-CA1 Lotilaner, an ingredient in Credelio Quattro/Credelio Quattro-CA1, belongs to the isoxazoline class and has been associated with neurologic adverse reactions like tremors, incoordination, and seizures even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Dogs should be tested for existing heartworm infections before Credelio Quattro/Credelio Quattro-CA1 administration as it is not effective against adult heartworms. The safe use in breeding, pregnant, or lactating dogs has not been evaluated. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. Credelio Quattro-CA1 is conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-619. If you suspect that your dog is infested with NWS larvae, seek veterinary care immediately for treatment to include removal of larvae and appropriate wound care. For complete safety information, please see the Credelio Quattro/Credelio Quattro-CA1 product label or ask your veterinarian. Emergency Use Authorization of Credelio (lotilaner) Chewable Tablets for New World Screwworm (NWS) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Credelio (lotilaner) chewable tablets for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. Credelio is not approved for this use. Credelio (lotilaner) is approved for other uses in dogs and puppies. For additional information on the EUA, please refer to the Credelio NWS Fact Sheet . Limitations of Authorized Use Credelio (lotilaner) chewable tablets is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Credelio (lotilaner) chewable tablets under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Indications for Credelio Credelio kills adult fleas and is indicated for the treatment and prevention of flea infestations and treatment and control of tick infestations (lone star tick, American dog tick, black-legged tick, brown dog tick, and longhorned tick) for one month in dogs and puppies 8 weeks and older and 4.4 pounds or greater. Credelio is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks. Important Safety Information for Credelio Lotilaner is a member of the isoxazoline class of drugs. This class has been associated with neurologic adverse reactions including tremors, incoordination, and seizures. Seizures have been reported in dogs receiving this class of drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of Credelio in breeding, pregnant or lactating dogs has not been evaluated. The most frequently reported adverse reactions are weight loss, elevated blood urea nitrogen, increased urination, and diarrhea. For complete safety information, please see Credelio product label or ask your veterinarian. Emergency Use Authorization for Credelio CAT (lotilaner) for New World Screwworm (NWS) The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Credelio CAT (lotilaner) for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in cats and kittens. Credelio CAT is not approved for this use. Credelio CAT is approved for other uses. For additional information on the EUA, please refer to the Credelio Cat NWS Fact Sheet. Limitations of Authorized Use Credelio CAT (lotilaner) is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Credelio CAT (lotilaner) under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Indications for Credelio CAT Credelio CAT kills adult fleas and is indicated for the treatment and prevention of flea infestations for one month in cats and kittens 8 weeks of age and older and weighing 2 pounds or greater. Credelio CAT is also indicated for treatment and control of black-legged tick infestations for one month in cats and kittens 6 months of age and older and weighing 2 pounds or greater. Important Safety Information for Credelio CAT Lotilaner is a member of the isoxazoline class of drugs. This class has been associated with neurologic adverse reactions including tremors, incoordination and seizures. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders. The safety of Credelio CAT has not been established in breeding, pregnant and lactating cats. The effectiveness of Credelio CAT against black-legged ticks in kittens less than 6 months of age has not been evaluated. The most frequently reported adverse reactions are weight loss, rapid breathing and vomiting. For complete safety information, please see Credelio CAT product label or ask your veterinarian. Emergency Use Authorization of Negasunt Powder (coumaphos, propoxur, and sulfanilamide topical powder) for New World Screwworm (NWS) WARNING: Neurotoxicity. Read full Fact Sheet for complete information. Coumaphos and propoxur can cause neurotoxicity. May be fatal if swallowed. May be fatal if inhaled. Harmful if absorbed through skin. Causes moderate eye irritation. Do not breathe dust. Avoid contact with eyes, skin, or clothing. Use only with appropriate personal protective equipment (PPE): coveralls worn over long-sleeve shirt and long pants, shoes, socks, and protective eyewear; chemical-resistant gloves made of barrier laminate, butyl rubber (≥ 14 mils), nitrile rubber (≥14 mils), neoprene rubber (>14 mils), natural rubber (≥14 mils), polyethylene, polyvinyl chloride (PVC) ≥14 mils, or Viton (>14 mils); and a minimum of a NIOSH-approved elastomeric half mask respirator consisting of protection factor (PF) 10 fitted with organic vapor (OV) cartridges and combination R or P filters; or a NIOSH-approved gas mask with OV canisters; or a NIOSH-approved powered air purifying respirator with OV cartridges and combination HE filters. This product is toxic to mammals, birds, fish, and aquatic invertebrates. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product Negasunt Powder for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia homnivorax) larvae (myiasis) in cattle, swine, goats, sheep, horses, donkeys, domestic hybrid equids, and captive wild, exotic, and zoo mammals. Negasunt Powder is not approved for this use. For use by employees of federal, state, local, and federally recognized tribal agencies, and persons working under their authority and at their direction. Also for use by or on the order of a licensed veterinarian in NWS infested zones and adjacent surveillance zones as defined by the U.S. Department of Agriculture (USDA). For additional information on the EUA and for complete safety information, please refer to the  Negasunt Powder NWS Fact Sheet. Limitations of Authorized Use It is a violation of federal law to use this drug product other than as directed in the authorized Fact Sheet. Treated animals must not be slaughtered for human consumption within 28 days of the last treatment. A milk discard time has not been established for this product; do not use in animals producing milk for human consumption. A withdrawal period has not been established for this product in pre-ruminating calves; treated calves and calves born to treated cows must not be processed for veal. Do not use in horses intended for human consumption. Do not use in domestic indoor pets (e.g., dogs, cats, rodents, rabbits) nor in residences. Do not use in birds. Do not use in free-ranging wildlife. To avoid overexposure, each individual person cannot treat more than 3 large wounds (>2 inches diameter) a day or more than 30 small superficial wounds (≤2 inches diameter) a day (or an equivalent thereof) with Negasunt Powder or any other coumaphos-containing products. Negasunt Powder is authorized for this use only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Negasunt Powder under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner. Federal law prohibits the extra-label use of this drug. Additional Important Safety Information Not for use in humans. Keep out of reach of children. Only handlers wearing required PPE may be in the area during application. Do not apply in a confined, non-ventilated area; provide thorough ventilation. Call a poison control center or doctor immediately for treatment advice if Negusant Powder is swallowed, inhaled, on skin or clothing, or in eyes. Sulfonamides are contraindicated in animals that are hypersensitive to them and in animals with severe renal or hepatic impairment. For external use only on animals. Do not contaminate water, feed, troughs, feed handling equipment, or milk or meat handling equipment. Use with caution in very young, weak, or debilitated animals. In the case of overdose, treat with atropine sulfate or pralidoxine chloride (2-PAM) as soon as possible. The most common adverse reactions associated with organophosphate and carbamate toxicity in animals include frequent urination and defecation, muscle twitching, and watering eyes. Important Information about Tanidil Tanidil™ is an unregistered product for distribution and use only under a Section 18 emergency exemption. The Section 18 labeling must be in the possession of the user at the time of pesticide application. This product may only be used to prevent or control New World screwworm in and on animal wounds on labeled animal host species. For use only by federal, state, local, and federally recognized tribal agencies, and persons working under their supervision; personnel at quarantine stations and areas; veterinarians; veterinarians or certified applicators at livestock and game facilities, zoos, wildlife facilities, animal rehabilitation centers; and wildlife professionals. Read the entire label. This product must be used strictly in accordance with this label's precautionary statements and use directions, as well as with all applicable state and federal laws and regulations. Please visit the Tanidil fact sheet for more information. Use Period: This exemption is effective on April 27, 2026 and expires on April 27, 2029. No applications of Tanidil may be made under the emergency exemption before its effective date or after its expiration date. Credelio, Credelio Quattro, Negasunt, Tanidil, Catron, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2026 Elanco or its affiliates Investor Contact: Tiffany Kanaga (765) 740-0314 [email protected] Media Contact: Colleen Parr Dekker (317) 989-7011 [email protected] Media Contact: Mika Takahashi (765) 335-4070 [email protected] Media Contact: Season Solorio (765) 316-0233 [email protected]   SOURCE Elanco Animal Health 21% more press release views with Request a Demo

补充2026年6月1日，CDE更新信息： 时间/部门/文件标题 文件链接 20260601CDE关于药审中心网站“儿童用药专栏”开通“儿童用药研发常见/共性问题及一般性答复一问一答”栏目的通知 20260601CDE关于药审中心网站“儿童用药专栏”开通“儿童用药研发常见 共性问题及一般性答复一问一答”栏目的通知.pdf另外，新增了“优先审评审批的儿童用药信息清单”，只有一个标题，点击进入是清单具体内容。 CDE“儿童用药专栏”特色很鲜明，仿佛进入童话世界，主题也是可爱型的。这个专栏是在2021年6月1日开通（20210531CDE关于开通“儿童用药专栏”的通知.pdf），又在今年六一增加新内容，已经有7个栏目： ①.公开征求意见：截止目前（2026年6月2日）该栏目显示15条信息，包含纳入试点项目的公示，但昨天“中国药审”公众号发布：“星光计划”已纳入13个儿童抗肿瘤药物，为什么少很多？ 公开征求意见 “中国药审”公众号界面 向下滑动查看更多 ②.政策法规：目前显示20条信息 向下滑动查看更多 ③.指导原则：目前显示24条信息 向下滑动查看更多 ④.上市信息：分为两个模块：“上市信息”（21条）和“优先审评审批的儿童用药信息清单”（96条），官网双击清单中某一药品信息可查看详情，包括适应症、说明书等。 上市信息（21条） 优先审评审批的儿童用药信息清单（96条） 向下滑动查看更多 “优先审评审批的儿童用药信息清单”（特有）清单-20260601.xlsx 序号 批准日期 药品名称 企业名称 1 2026/3/25 维生素K1注射液 CHEPLAPHARM Arzneimittel GmbH 2 2026/3/3 玛巴洛沙韦干混悬剂 Roche Pharma (Schweiz) AG 3 2026/2/10 托吡酯口服溶液 杭州和康药业有限公司 4 2025/12/30 肾上腺素注射液 成都诺和晟鸿生物制药有限公司 5 2025/12/30 维生素K1注射液 合肥亿帆生物制药有限公司 6 2025/11/18 菖麻熄风颗粒 黑龙江省济仁药业有限公司 7 2025/11/18 托吡酯口服溶液 海南斯达制药有限公司 8 2025/9/30 马来酸噻吗洛尔凝胶 北京梅尔森医药技术开发有限公司 9 2025/9/2 来特莫韦片（Ⅱ） Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. 10 2025/9/2 复方磺胺甲噁唑注射液 华夏生生药业（北京）有限公司 11 2025/8/8 肾上腺素注射液 武汉久安药物研究院有限公司 12 2025/7/8 褪黑素颗粒 Nobelpharma Co., Ltd. 13 2025/5/27 芦沃美替尼片 上海复星医药产业发展有限公司 14 2025/4/22 维生素K1注射液 海南倍特药业有限公司 15 2025/2/25 吗替麦考酚酯干混悬剂 杭州中美华东制药有限公司 16 2025/2/20 盐酸胍法辛缓释片 四川百利药业有限责任公司 17 2025/1/24 巴氯芬口服溶液 成都倍特得诺药业有限公司 18 2025/1/24 巯嘌呤片（Ⅱ） 华润双鹤药业股份有限公司 19 2025/1/8 盐酸右哌甲酯缓释胶囊 河南中帅药业有限公司 20 2024/12/17 艾曲泊帕乙醇胺干混悬剂 山东则正医药技术有限公司 21 2024/12/6 注射用利纳西普 Kiniksa Pharmaceuticals (UK), Ltd. 22 2024/12/6 伐莫洛龙口服混悬液 Santhera Pharmaceuticals（Deutschland）GmbH 23 2024/12/1 奥德昔巴特胶囊 Ipsen Pharma 24 2024/11/22 本维莫德乳膏 上海泽德曼医药科技有限公司 25 2024/11/5 盐酸米诺环素泡沫剂 Journey Medical Corporation 26 2024/7/9 盐酸万古霉素胶囊 时森海（杭州）医药科技有限公司 27 2024/7/9 加奈索酮口服混悬剂 Marinus Pharmaceuticals, Inc. 28 2024/6/28 苯乙酸钠苯甲酸钠注射用浓溶液 安徽沃泰生物医药有限公司 29 2024/6/4 磷酸二氢钠磷酸氢二钠颗粒 嘉实（湖南）医药科技有限公司 30 2024/5/21 醋酸氟氢可的松片 ASPEN PHARMA TRADING LIMITED 31 2024/5/21 盐酸替洛利生片 Bioprojet Pharma 32 2024/3/12 硫酸阿托品滴眼液 沈阳兴齐眼药股份有限公司 33 2024/2/23 阿布昔替尼片 Pfizer Inc. 34 2024/2/6 醋酸锌片 Nobelpharma Co.,Ltd. 35 2024/1/16 对乙酰氨基酚栓 浙江尔婴药品有限公司 36 2024/1/9 二氮嗪口服混悬液 宿州亿帆药业有限公司 37 2023/12/29 盐酸哌甲酯缓释干混悬剂 NextWave Pharmaceuticals Inc, a subsidiary of Tris Pharma Inc 38 2023/12/29 玛巴洛沙韦干混悬剂 Roche Pharma (Schweiz) AG 39 2023/12/29 盐酸曲恩汀片 Orphalan 40 2023/12/26 尼塞韦单抗注射液 AstraZeneca AB 41 2023/12/13 盐酸哌甲酯缓释咀嚼片 NextWave Pharmaceuticals Inc,a subsidiary of Tris Pharma Inc 42 2023/11/14 布洛芬注射液 成都硕德药业有限公司 43 2023/9/5 卡谷氨酸分散片 远大医药（中国）有限公司 44 2023/8/29 醋酸氟氢可的松片 合肥市未来药物开发有限公司 45 2023/8/22 盐酸右美托咪定鼻喷雾剂 上海恒瑞医药有限公司 46 2023/7/25 司替戊醇干混悬剂 石家庄四药有限公司 47 2023/6/27 卡谷氨酸分散片 Recordati Rare Diseases 48 2023/6/9 西罗莫司凝胶 Nobelpharma Co.,Ltd. 49 2023/5/29 氯马昔巴特口服溶液 Mirum Pharmaceuticals, Inc. 50 2023/5/12 吡仑帕奈口服混悬液 Eisai Europe Limited 51 2023/4/28 硫酸氢司美替尼胶囊 ASTRAZENECA UK LIMITED 52 2023/4/28 地高辛注射液 成都倍特药业股份有限公司 53 2023/3/7 注射用双羟萘酸曲普瑞林 IPSEN PHARMA 54 2023/2/21 蔗糖羟基氧化铁咀嚼片 Vifor Fresenius Medical Care Renal Pharma Ltd. 55 2023/2/20 药用炭颗粒 Norit Nederland B.V. 56 2023/2/14 尼替西农胶囊 Swedish Orphan Biovitrum International AB 57 2023/2/14 尼替西农口服混悬液 Swedish Orphan Biovitrum International AB 58 2023/1/10 环磷酰胺胶囊（25 mg规格） 江苏恒瑞医药股份有限公司 59 2022/12/26 注射用盐酸美法仑 西安力邦制药有限公司 60 2022/11/30 那西妥单抗注射液 Y-mAbs Therapeutics, Inc. 61 2022/9/14 氯巴占片 宜昌人福药业有限责任公司 62 2022/9/14 复方聚乙二醇（3350）电解质散 舒泰神（北京）生物制药股份有限公司 63 2022/7/19 阿立哌唑口服溶液 四川大冢制药有限公司 64 2022/6/30 盐酸可乐定缓释片 力品药业（厦门）股份有限公司 65 2022/6/28 重组人生长激素注射液 长春金赛药业有限责任公司 66 2022/6/23 硫酸拉罗替尼口服溶液 Bayer AG 67 2022/4/29 利伐沙班干混悬剂 Bayer AG 68 2022/4/27 注射用贝林妥欧单抗 Amgen Inc. 69 2022/4/12 盐酸咪达唑仑口服溶液 江苏恩华药业股份有限公司 70 2022/3/8 吸入用一氧化氮 INO Therapeutics LLC 71 2022/3/1 盐酸利多卡因粉末无针注射皮内给药系统 Powder Pharmaceuticals, Inc. 72 2022/2/18 乌帕替尼缓释片 AbbVie Deutschland GmbH & Co.KG 73 2022/1/7 氨己烯酸口服溶液用散 Dr. Reddy's Laboratories Limited 74 2021/11/1 达妥昔单抗β注射液 Recordati Netherlands B.V. 75 2021/9/13 注射用人生长激素 安徽安科生物工程（集团）股份有限公司 76 2021/9/9 恩替卡韦颗粒 湖南华纳大药厂股份有限公司 77 2021/9/9 盐酸头孢卡品酯颗粒 SHIONOGI & Co. 78 2021/9/7 度普利尤单抗注射液 Sanofi-aventis groupe 79 2021/8/19 盐酸普萘洛尔口服溶液 河南百年康鑫药业有限公司 80 2021/8/18 盐酸普萘洛尔口服溶液 亚宝药业四川制药有限公司 81 2021/7/12 Sabin株脊髓灰质炎灭活疫苗（Vero细胞） 北京科兴生物制品有限公司 82 2021/6/25 氨己烯酸口服溶液用散 Aucta Pharmaceuticals, Inc. 83 2021/5/13 苯丁酸钠颗粒 兆科药业（广州）有限公司 84 2021/4/27 咪达唑仑口服溶液 宜昌人福药业有限责任公司 85 2021/3/30 水合氯醛/糖浆组合包装 特丰制药有限公司 86 2020/12/2 注射用贝利尤单抗 GlaxoSmithKline (Ireland) Limited 87 2020/11/17 恩替卡韦口服溶液 扬子江药业集团江苏制药股份有限公司 88 2020/9/30 A群C群脑膜炎球菌多糖结合疫苗 成都欧林生物科技股份有限公司 89 2020/8/26 他克莫司颗粒 Astellas Pharma Europe B.V. 90 2020/4/2 冻干鼻喷流感减毒活疫苗 长春百克生物科技股份公司 91 2019/12/30 13价肺炎球菌多糖结合疫苗 玉溪沃森生物技术有限公司 92 2019/12/30 水合氯醛灌肠剂 特丰制药有限公司 93 2019/12/18 芍麻止痉颗粒 天士力医药集团股份有限公司 94 2019/11/18 咪达唑仑口颊粘膜溶液 吉林津升制药有限公司 95 2019/9/5 波生坦分散片 Actelion Pharmaceuticals Ltd 96 2019/6/6 重组人生长激素注射液 安徽安科生物工程(集团)股份有限公司 ⑤.培训信息：3条信息 ⑥.宣传报道：51条信息 向下滑动查看更多 ⑦.一问一答：“儿童用药专栏”特有内容，认真学习学习。 目前有9个主题，具体内容如下： 1 关于《化学药品和治疗用生物制品说明书中儿童用药相关信息撰写的技术指导原则（试行）》您可能关心的问题大家在问：在什么情况下需要更新说明书的儿童信息？解锁答案 供您参考：当出现以下情况时，及时提交更新说明书的申请：     ·获得新的儿童安全性或有效性数据。     ·监管机构基于不良反应监测结果要求修订。     ·发现新的风险或原有风险的特征发生变化。 2 关于《儿童抗肿瘤药物临床研发技术指导原则》您可能关心的问题大家在问：儿童抗肿瘤药研发的总体思路是什么？解锁答案   供您参考：研发需同时遵循儿童用药研发的一般规律和抗肿瘤药物研发的特殊原则。核心考量包括：     ·将儿童适应症开发纳入药物整体临床开发计划。     ·优先保护患儿权益，避免不必要的儿童研究。     ·一般情况下，遵循“按年龄顺序”（成人→青少年→小年龄段儿童）和“按疾病阶段”（末线/难治复发→前线/初治）逐步推进研发。     ·通常以在成人患者中观察到风险可控且具备抗肿瘤活性的剂量作为启动儿童研究的前提。大家在问：基于肿瘤类型，研发路径如何选择？ 解锁答案   供您参考：根据是否为成人儿童共患肿瘤，路径有所不同：     ·成人儿童共患肿瘤：疾病特征可能随年龄增长趋近于成人。可根据目标适应症的年龄分布特点，在符合儿童肿瘤药物研发的一般原则下，合理制定研发计划。     ·儿童特有肿瘤：临床治疗手段更有限，临床需求更为迫切，可考虑采用更为积极的研发策略（如更早开展儿童研究）。关键试验常采用随机对照或单臂试验设计。通常先在青少年中开展试验，再逐步推进至小年龄段儿童。 3 关于《儿童用药口感设计与评价的技术指导原则（试行）》您可能关心的问题大家在问：什么是“口感”？评价维度包括什么？  解锁答案供您参考：     “口感”通常是指口服制剂的剂型、质地、容积或体积（大小和形状）、气味、味道、余味等通过口腔感受的特性，其核心评价维度包括“易吞咽性”和“适口性”。大家在问：为什么需要关注儿童用药的口感评价？解锁答案供您参考：儿童生理和心理发育尚未成熟，对不良感觉（如苦味）的耐受性通常比成人差。口感不佳的药液会导致孩子恐惧，抗拒服药，影响服药依从性，可能导致无法达到预期的疾病治疗效果，或因体内药物暴露量不稳定带来安全性隐患。大家在问：如何理解“良好口感”？解锁答案供您参考：儿童用药的良好口感并非追求“美味”。良好口感通常定位在“中性味道（没有特殊味道或无味道）”或“普遍可接受的味道”，同时，能够易于吞咽，服药后口腔里的残留感持续时间短，不会引起明显不适。考虑到可能增加儿童误服、滥用的风险，因此，通常不建议将药物设计成对儿童有“明显诱惑力”的口感。大家在问：如何进行口感设计？解锁答案供您参考：需要考虑以下方面：药物的基本味道（苦、甜、酸、涩等）、嗅觉（气味）、口腔感觉（涩感、灼烧感、沙粒感、油腻感等）以及余味。不同剂型口感评价的侧重点有所差别，建议根据剂型特性进行设计和评价。同时，需要考虑目标治疗人群年龄段发育特征及味觉感知、心理认知和吞咽能力等。大家在问：口感的评价方法是什么？解锁答案供您参考：采用主客观结合的评价方法：可以使用如“电子舌”等客观、可重复、可量化的分析仪器来评估整体的味觉情况，辅助筛选掩味策略。根据药物研发定位，在符合伦理要求的前提下，可进行人体感官评价（包括在儿童患者中进行评价），直接收集感受数据。大家在问：已上市的成人用药品计划扩展用于儿童时，是否需要关注口感？解锁答案供您参考：如果已上市的成人用药品计划将目标治疗人群扩展至12岁以下儿童，需要提供口感适合于目标儿童患者的证据。如果现有证据充分可靠，一般无需额外进行儿童口感评价。 4 关于《真实世界研究支持儿童药物研发与审评的技术指导原则（试行）》您可能关心的问题大家在问：真实世界研究（RWS）与随机对照临床试验（RCT）是什么关系？通常在儿童用药研发中发挥什么作用？  解锁答案供您参考：现阶段，RWS与RCT并非相互取代，通常表现为“互为补充、互为支撑”的关系。选择哪种方法或兼而有之，取决于疾病特征、目标人群、药物性质和研究目的的综合考量，核心原则是确保能充分评价药物的安全性和有效性。儿童用药研发中，RCT如果涉及伦理挑战、入组困难、样本量有限等问题，RWS可以作为RCT的重要补充，为儿童用药的安全性、有效性、用药方案优化等提供证据支持，从而加快研发进程。大家在问：真实世界证据（RWE）在儿童用药研发中涉及哪些应用范围？  解锁答案供您参考：     ·提供安全性证据：尤其是长期用药的安全性风险（如对生长发育的影响）、罕见不良反应的识别等。     ·支持用药方案优化：例如扩展或缩窄适用人群（如向低龄儿童扩展）、优化给药剂量或频次（如根据体重细化剂量）、完善给药操作（如与食物同服）等。     ·评价长期临床获益：对在RCT中以替代终点获批的药物，在真实世界中观察其长期临床结局。     ·提供剂量依据或验证剂量合理性：为临床经验性给药提供剂量参考，或验证通过外推模型确定的儿童剂量的合理性。     ·其他：如药物经济学评价、生活质量研究等。大家在问：在儿童用药研发中应用RWS需要注意哪些问题？  解锁答案供您参考：     ·数据质量：特别关注数据的来源与质量。数据应可靠、完整、准确，并能代表目标人群。     ·伦理与法规：RWS同样需要遵循临床研究的一般原则和儿童临床研究的特殊考虑（如知情同意）。     ·技术可行性：考虑医疗机构的信息化水平、数据采集条件等能否满足研究需求。 5 关于《儿童用化学药品改良型新药临床试验技术指导原则（试行）》您可能关心的问题大家在问：什么是“开发/扩展儿童应用”？解锁答案供您参考：包括两种常见情况：一是将已批准的成人应用扩展至儿童应用（通常同时改变剂型、规格）；二是在已批准的儿童应用范围基础上扩展新的应用范围（如增加新适应症、扩展至更低龄儿童、优化剂量方案，同时也可能改变剂型、规格等制剂特征）。大家在问：儿童用改良型新药临床研究设计的基本原则是什么？解锁答案供您参考：尽可能利用已有研究证据，减少在儿童中开展不必要的重复研究。有明确的研究目的，避免在儿童中开展明显缺乏治疗获益或安全性风险难以预期的临床研究。例如，采用模型/模拟进行预测和外推，获得拟定剂量后再在儿童中开展小规模的临床试验。大家在问：儿童用改良型新药的临床研究设计需要重点关注什么？解锁答案供您参考：开发/扩展儿童应用时，通常需要开展新的目标儿童人群的临床试验，以提供该活性成分在新的儿童治疗范围使用的研究证据，支持获益-风险评估。     ·由成人向儿童扩展：需重点关注目标治疗人群与已批准应用人群在疾病病因和病理生理过程方面的相似性，并据此探索给药剂量，通过临床试验确证获益与风险。     ·扩展新的儿童应用范围：需重点关注不同疾病间的治疗反应和可能的药物组织分布差异，从而研究和探索剂量方案。大家在问：如何评价儿童用改良型新药的“临床优势”？解锁答案供您参考：     ·重要区别：“具备临床价值”并非等同于“认可临床优势”。临床优势的判断需结合未被满足的临床需求程度，并与已有上市药品或治疗手段进行比较后进行综合考量。     ·儿童特异性：在成人应用中可能不被认为有临床价值的改良（如片剂改为口服溶液），在低龄儿童中可能被视为具有临床价值甚至临床优势。     ·动态变化：临床优势的判断标准可能随着临床诊疗方式的进步及药品类型的丰富而发生变化。大家在问：是否鼓励多目标同时优化？解锁答案供您参考：鼓励在一次改良开发过程中，兼顾与儿童应用相关的多方面优化。例如，在增加儿童适应症的同时，开发适宜该年龄段儿童的剂型、规格和口感等。大家在问：如何考虑儿童用新复方制剂？解锁答案供您参考：不鼓励在缺乏明确的临床需求及药物联合使用证据的情况下，开发儿童使用的复方制剂。大家在问：对于特殊或复杂剂型有什么考虑？解锁答案供您参考：开发特殊或复杂剂型（如吸入制剂、复杂缓控释制剂）的儿童用改良型新药时，应以符合儿童生长发育特征及用药习惯为前提。研究设计应纳入儿童特征考虑，并最终提供充分证据支持其在儿童中应用的预期疗效和安全性。 6 关于《儿童用药（化学药品）药学开发指导原则（试行）》您可能关心的问题大家在问：选择给药途径和剂型时需考虑什么？  解锁答案供您参考：选择给药途径和剂型时，在遵循常规药物开发方法的基础上，重点考虑儿童的生理和病理特征，确保制剂产品的计量准确性、给药便利性、患者可接受性等。大家在问：关于选择辅料需要注意什么？  解锁答案供您参考：辅料选择是儿童用药（尤其是低龄儿童）开发的关键环节，需重点关注：     ·安全性：充分评估辅料种类和用量在儿童中使用的安全性。某些成人耐受的辅料可能对儿童（尤其新生儿、婴幼儿）造成风险。     ·必要性：在降低风险以及确保产品的疗效、稳定性、适口性、微生物控制和剂量均匀性的前提下，应尽可能使用最少种类和最低用量的辅料，尽量避免使用非必要的辅料（如着色剂）。 7 关于《成人用药数据外推至儿科人群的定量方法学指导原则（试行）》您可能关心的问题大家在问：数据外推的前提是什么？  解锁答案供您参考：数据外推并非简单照搬，其核心前提是基于科学证据评估成人与儿童在疾病进程、治疗反应及药物暴露-效应关系上的相似性。只有在证明这些关键方面相似的基础上，外推才具有科学合理性。大家在问：定量外推方法主要涉及哪些模型？  解锁答案供您参考：根据不同的研究目的选择的定量方法有所不同。当涉及暴露量预测时，可基于药物特征、现有数据以及研发阶段等选择PBPK模型或群体PK模型，同时针对特定参数和人群，可以考虑异速生长法或生长发育模型等。当涉及暴露-效应分析时，需考虑建立暴露-效应关系模型，如Emax模型等。此外，当评价两人群疾病相似时，可考虑建立疾病进展模型。因此需结合所需解决的研究问题，采用合适的模型以支持研究目的。大家在问：外推安全性数据应注意什么？  解锁答案供您参考：安全性数据通常不能完全外推。成人数据可能无法预测儿童特有的不良反应（尤其对生长发育的影响）。因此，即使纳入外推策略，也需考虑在目标儿童中收集相应的安全性数据。大家在问：如何选择合适的外推方法？  解锁答案供您参考：主要基于所需解决的科学问题，同时考虑药物特性、已有数据的丰富程度等。如PBPK模型可结合生理机制描述药物PK的变化，但需要较多且准确的药物制剂和生理参数等。群体PK建模相对简单，但首先需要生物样本的采集，且难以从机制上表征儿童的生理变化过程。通常建议采用多种方法相互验证，并优先选择经过科学验证和广泛认可的模型。 8 关于《生理药代动力学模型在儿科人群药物研发中应用的技术指导原则》您可能关心的问题大家在问：儿童PBPK模型构建的一般策略是什么？解锁答案供您参考：儿童PBPK模型通常首先建立在成人数据的基础上。在成人模型验证成功后，通过调整与个体发育相关的系统特异性参数（如体重、器官成熟度、酶活性等），将其外推和转化为适用于儿童的模型。大家在问：儿童PBPK建模一般需要哪些类型的数据？解锁答案供您参考：     ·系统特异性参数：与人体有关的参数，例如解剖参数、器官血流、组织组成、酶和转运蛋白的丰度等。儿童模型需特别关注体重、器官成熟度等的影响。     ·药物特异性参数：包括药物理化性质、体外和体内溶出、吸收及处置药代动力学参数等。大家在问：应用儿童PBPK模型有何潜在风险？如何控制？解锁答案供您参考：主要风险：由于对儿童生长发育及生理病理特征的了解尚处于积累阶段，以及相关临床前和临床数据相对有限，导致模型存在不确定性。风险控制措施：     ·遵循逐步外推原则：模型通常先经成人和/或较大年龄儿童数据验证和优化后，再用于预测较小年龄儿童的PK行为。     ·审慎决策：认识到模型的预测性和探索性，充分评估模型不确定性对决策的影响。     ·临床试验风险控制：当基于不确定性较高的模型设计儿童临床试验时，制定相应的风险控制措施，如密切的安全性监测、采用更保守的起始剂量等。大家在问：PBPK模型在儿童剂量探索和优化中如何应用？解锁答案供您参考：     ·剂量探索：模型可用于预测首次儿童临床试验的起始剂量，或探索不同年龄亚组的剂量。但对于新生儿或婴幼儿，由于生理参数不确定性大，鼓励结合合理的临床前数据进行补充预测。     ·给药方案优化：对于已有较充分数据的药物，基于预设的安全有效暴露范围，模型可模拟并提供给药剂量、给药间隔、负荷剂量等优化建议。大家在问：PBPK模型如何支持儿童用剂型开发？解锁答案供您参考：儿童的生理因素差异可能导致其对药物的吸收和处置与成人不同。PBPK模型可以整合制剂特性（如溶出行为）和儿童生理特点，模拟预测不同剂型在儿童体内的PK特征。在数据充分的情况下，可以用于减少在儿童中开展不必要的临床试验。大家在问：PBPK模型相关的报告有何要求？解锁答案供您参考：建议根据模型的使用目的和重要性决定提交材料的详略：     ·支持关键决策或作为注册关键证据：需要提交完整详细的报告，内容参照《模型引导的药物研发技术指导原则》，全面展示模型构建、验证、应用及不确定性分析的全过程。     ·仅用于内部研发决策辅助：可以提交一份简要的综述进行说明。与药审中心进行沟通交流时，若以PBPK模型作为支持性依据，通常建议准备并提交完整报告以便于讨论和评估。 9 关于《儿童药物临床试验安全信息评估与报告技术指导原则（试行）》您可能关心的问题大家在问：儿童参与者知情同意有何特殊考虑？  解锁答案供您参考：严格遵循《药物临床试验质量管理规范》（GCP）。一般对于8周岁及以上的儿童，除必须获得其监护人的知情同意外，还应征得本人同意并签署知情同意书。整个过程需关注监护人及儿童的理解与情绪状态，并获得伦理委员会批准。大家在问：儿童临床试验中各参与方的职责如何界定？解锁答案供您参考：申办者是药物警戒活动的责任主体，全面负责计划的制定与实施，始于临床试验开始之前，并贯穿全程。所有参与方（包括临床试验机构、研究者、伦理委员会及其监护人等）需协同开展工作，确保参与者安全。大家在问：儿童临床试验可能面临哪些因信息缺失带来的风险？解锁答案供您参考：因信息缺失带来的风险主要包括：     ·现有安全性数据不足以支持新试验开展。     ·药代动力学（PK）或剂量-效应关系数据不充分，可能导致给药剂量不当。     ·常规安全性数据收集可能无法及时提示潜在安全信号。     ·剂型、口感等不适宜不同年龄段儿童，可能导致用药错误或依从性差。大家在问：风险管理计划（RMP）在儿童临床试验中如何应用？解锁答案供您参考：     ·早期制定：鼓励在研发初期制定风险管理计划，并随试验进展持续更新。     ·参考多方数据：参考非临床研究（如幼龄动物毒理学数据）、成人临床研究数据等，以帮助识别儿童潜在风险。     ·重点分析：重点分析药物与靶器官相互作用随年龄的变化、个体发育对药物处置的影响、对器官发育的长期影响、不同于成人的潜在不良反应、对免疫系统成熟的影响等方面。     ·计划上市后研究：若存在重要儿童安全风险，需考虑开展上市后安全性研究。大家在问：个例安全性报告（ICSR）对于儿童参与者有何特殊要求？解锁答案供您参考：详细准确地记录：     ·年龄信息：早产儿提供胎龄信息；新生儿提供出生天数、胎龄信息；婴幼儿提供天龄或月龄；儿童与青少年提供月龄或年龄等。     ·发育指标：青春期发育阶段、认知和运动发育关键阶段等。     ·药物暴露：怀孕或妊娠期间发生药物暴露、母乳导致药物暴露等。     ·药物信息：适应症、剂型、剂量等。     ·不良反应发生时患儿的体重与身高信息。     ·专业评估：考虑与成人的差异，按年龄亚组分层分析，并配备有儿科经验的人员审核。大家在问：研发期间安全性更新报告（DSUR）包含哪些儿童相关的内容？解锁答案供您参考：     DSUR需说明儿童或不同年龄亚组中新的安全性问题，包括超说明书用药情况和已识别的任何不良反应信号，并说明药物暴露量及计算方法。