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The Second Committee on New Drugs determines the product may be approved and directs reporting to the relevant pharmaceutical affairs authority. The document states the orphan-drug status, key special-mention items, and outlines approval conditions requiring a post-marketing drug use-results survey plus ongoing collection of safety and efficacy data.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/report-on-the-deliberation-results-march-15-2013/394311/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/report-on-the-deliberation-results-march-15-2013/394311.png","ImageObject",300,407,{"name":92,"@type":93},"nayy☆","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-05","2026-09-26",true,{"@type":102,"interactionType":103,"userInteractionCount":34},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What approval outcome is concluded for the product?","Question",{"text":112,"@type":113},"The Second Committee on New Drugs concluded that the product may be approved and that the result should be presented to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Why are the post-marketing survey requirements emphasized?",{"text":117,"@type":113},"Because the product is an orphan drug and Japanese clinical-study subjects are extremely few, applicants must conduct a post-marketing drug use-results survey covering all treated patients until sufficient patient data are accumulated.",{"name":119,"@type":110,"acceptedAnswer":120},"What is the indicated use and typical dosage described?",{"text":121,"@type":113},"The product is indicated for visualization of malignant tissue during surgical resection of malignant glioma. The usual adult dosage is 20 mg/kg Aminolevulinic Acid Hydrochloride as an oral solution administered 3 hours (range 2–4 hours) before anesthesia induction.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},394311,1790739966,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":34,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},962090893153,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Report on the Deliberation Results  \nMarch 15, 2013  \nEvaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare  \n[Brand name]  \n[Non-proprietary name][Applicant]  \n[Date of application]  \n(a) Alabel Oral 1.5 g and (b) Alaglio Oral 1.5g Aminolevulinic Acid Hydrochloride (JAN*)  \n(a) Nobelpharma Co., Ltd. and (b) SBI Pharmaceuticals Co., Ltd. July 5, 2012  \n[Results of deliberation]  \nIn the meeting held on March 13, 2013, the Second Committee on New Drugs concluded that the product may be approved and that this result should be presented to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council.  \nThe product is not classified as a biological product or a specified biological product, the re-examination period is 10 years, and neither the drug substance nor the drug product is classified as a poisonous drug or a powerful drug.  \n[Conditions for approval]  \nThe applicant is required to conduct a post-marketing drug use-results survey over a certain period of time until the data about a certain number of patients are accumulated after market launch, covering all patients treated with the product, in order to understand background information about patients treated with the product because the product is an orphan drug and subjects for Japanese clinical studies are extremely few. At the same time, the data about the safety and efficacy of the product should be collected and necessary measures should be taken to ensure that the product is properly used.  \n*Japanese Accepted Name (modified INN)  \nThis English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version.  \nReview Report  \nMarch 5, 2013  \nPharmaceuticals and Medical Devices Agency  \nThe results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows.  \n[Brand name] (a) Alabel Oral 1.5 g and (b) Alaglio Oral 1.5 g [Non-proprietary name] Aminolevulinic Acid Hydrochloride  \n[Name of applicant] (a) Nobelpharma Co., Ltd. and (b) SBI Pharmaceuticals Co., Ltd.[Date of application] July 5, 2012  \n[Dosage form/Strength] A lyophilized preparation containing 1.5 g of Aminolevulinic Acid  \nHydrochloride per vial  \n[Application classification] Prescription drug (1) Drug with a new active ingredient [Chemical structure]  \nMolecular formula: C5H9NO3·HCl  \nMolecular weight: 167.59  \nChemical name: 5-Amino-4-oxopentanoic acid monohydrochloride  \n[Items warranting special mention] Orphan drug (Notification No. 0914-1 from the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, dated September 14, 2010)  \n[Reviewing office] Office of New Drug II  \nThis English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version.  \nReview Results  \nMarch 5, 2013  \n[Brand name]  \n[Non-proprietary name][Name of applicant][Date of application]  \n(a) Alabel Oral 1.5 g and (b) Alaglio Oral 1.5 g Aminolevulinic Acid Hydrochloride  \n(a) Nobelpharma Co., Ltd. and (b) SBI Pharmaceuticals Co., Ltd. July 5, 2012  \n[Results of review]  \nBased on the submitted data, it is concluded that the efficacy of Alabel Oral 1.5 g and Alaglio Oral 1.5 g (hereinafter collectively referred to as “the product”) for visualization of malignant tissue during surgical resection of malignant glioma has been demonstrated and the safety is accep","cbCaidH9Eswyynyj","https://ap.wps.com/l/cbCaidH9Eswyynyj","pdf",407845,66,"English","# Report on the Deliberation Results\n## Evaluation and licensing authorities\n## Results and regulatory conclusion\n## Conditions for approval\n# Review Report\n## Product submission and classification\n## Indication and dosage\n## Special mention items","[{\"question\":\"What approval outcome is concluded for the product?\",\"answer\":\"The Second Committee on New Drugs concluded that the product may be approved and that the result should be presented to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council.\"},{\"question\":\"Why are the post-marketing survey requirements emphasized?\",\"answer\":\"Because the product is an orphan drug and Japanese clinical-study subjects are extremely few, applicants must conduct a post-marketing drug use-results survey covering all treated patients until sufficient patient data are accumulated.\"},{\"question\":\"What is the indicated use and typical dosage described?\",\"answer\":\"The product is indicated for visualization of malignant tissue during surgical resection of malignant glioma. The usual adult dosage is 20 mg/kg Aminolevulinic Acid Hydrochloride as an oral solution administered 3 hours (range 2–4 hours) before anesthesia induction.\"}]","Report on the Deliberation Results - March 15, 2013 | PDF",1790401955,166]