Harman Finochem Limited

Total Page:16

File Type:pdf, Size:1020Kb

Harman Finochem Limited Harman Finochem Limited PRODUCT LIST ANESTHETIC ANTIMUSCARINIC PROPOFOL + OXYBUTYNIN CHLORIDE / HCl + LIDOCAINE BASE + LIDOCAINE HCl + ANTIDIABETIC BUPIVACAINE BASE METFORMIN HCl + BUPIVACAINE HCl ANTIGOUT CENTRAL NERVOUS STIMULANT ALLOPURINOL + PHENOBARBITAL* + PHENOBARBITAL SODIUM* ANTICHOLINERGIC PHENYTOIN GLYCOPYRROLATE + PHENYTOIN SODIUM + VALPROIC ACID + ANTIPARKINSON DIVALPROEX SODIUM BENZTROPINE MESYLATE SODIUM VALPROATE + METHYLPHENIDATE HCl*+ CHOLINERGIC + METHYL PHENOBARBITAL* NEOSTIGMINE METHYLSULPHATE ANTIFUNGAL DIURETIC OXICONAZOLE NITRATE XIPAMIDE ANTIHYPERTENSIVE OPIOID ABSTINENCE SYNDROME BISOPROLOL FUMARATE+ METHADONE HCl + VALSARTAN DISODIUM * LEVOMETHADONE *+ ANXIOLYTIC NEUROMUSCULAR BLOCKING AGENT MEPROBAMATE + * SUCCINYLCHOLINE CHLORIDE MUSCLE RELAXANT LIPID REGULATING DRUG CARISOPRODOL FENOFIBRATE + ADRENERGICS / INHALANTS FENOFIBRIC ACID ISOPROTERENOL HCl CHOLINE FENOFIBRATE NOREPINEPHRINE BITARTRATE VITAMINS CALCIUM REPLENISHER VITAMIN B2-5 PHOSPHATE SODIUM+ 20 CALCIUM GLUCONATE METHYLCOBALAMIN CALCIUM SACCHARATE (**) Products covered by valid patents are being developed under experimental aims in base of Art. 10(6) of Directive 2004/27/EC, exclusively directed to obtain market authorizations of our customers' generic medicines. Samples for R&D use in the United States are available as permitted under 35 USC § 271 (e) (1). Products covered by valid patents in any country are not offered or supplied to these countries when such offer constitutes a patent infringement. OCTOBER’ 20 +COS- Certificate of Suitability/ * Controlled Substance/ USDMF/ TGA Note : DMF/ Documentation available on request Health.. Happiness... Harmony.... Worldwide. Harman Finochem Limited REGULATORY APPROVALS NAME OF API USDMF COS Allopurinol DMF # 17128 ü Benztropine Mesylate DMF # 033126 - Bisoprolol Fumarate - ü Carisoprodol DMF # 21064 - Choline Fenofibrate DMF # 28282 - Divalproex Sodium DMF # 21532 - Fenofibrate DMF # 23281 ü Fenofibric Acid DMF # 23855 - Glycopyrrolate DMF # 19710 ü Isoproterenol HCl DMF # 30707 APPLIED Levomethadone HCl - ü Lidocaine Base DMF # 27180 ü Lidocaine HCl DMF # 28784 ü Metformin HCl DMF # 15217 ü Meprobamate DMF # 20674 ü Methadone HCl - ü Methylphenidate HCl - ü Neostigmine Methylsulphate DMF # 30136 APPLIED Norepinephrine Bitartrate DMF # 033127 - Oxiconazole Nitrate DMF # 23625 - Oxybutynin HCl DMF # 22852 ü Phenobarbital DMF # 17823 ü Propofol DMF # 29006 ü Phenytoin Sodium DMF # 17862 ü Sodium Valproate - ü Succinylcholine Chloride DMF # 031986 - Valproic Acid - ü Vitamin B2-5 Phosphate Sodium - ü Tel.: +91 22 67330100 l Fax: +91 22 2652 8285 Email: [email protected] l Website: www.harmannochem.com Harman Finochem Limited PIPELINE PRODUCT LIST UNDER DEVELOPMENT PRODUCTS ANTICHOLINERGIC ANESTHETIC SOFPIRONIUM BROMIDE ROCURONIUM BROMIDE ANTIDIABETIC REMIMAZOLAM IMEGLIMIN ANTIHYPERTENSIVE ANALGESIC SACUBITRIL SODIUM TAPENTADOL HCl COPD / ASTHMA ANTIHYPERTENSIVE UMECLIDINIUM BROMIDE ATENOLOL ANTHELMINTIC PROPANOLOL ALBENDAZOLE AMLODIPINE BESYLATE ANTIVIRAL GUANFACINE HCL ACYCLOVIR ANTIDEPRESSANT VALACYCLOVIR NEFAZODONE EXPECTORANT DIURETIC GUAIFENESIN HYDROCHLOROTHIAZIDE NASAL DECONGESTANTS MUSCLE RELAXANT PHENYLEPHRINE METHOCARBAMOL CENTRAL NERVOUS SYSTEM LAXATIVE DEHYDRATED ALCOHOL LACTULOSE NUTRITION ANTIBACTERIAL SELENOUS ACID GLACIAL ACETIC ACID LAB VALIDATION COMPLETED ANTIHYPERTENSIVE ADRENERGICS/INHALANTS VALSARTAN/SACUBITRIL EPINEPHRINE BITARTRATE ANTIFUNGAL ANTICONVULSANT EFINACONAZOLE PRIMIDONE LULICONAZOLE ANTI DEPRESSANT ANTI-DIABETIC VILAZODONE ALOGLIPTIN COPD / ASTHMA CANAGLIFLOZIN ARFORMOTEROL TARTRATE DAPAGLIFLOZIN FORMOTEROL FUMARATE LINAGLIPTIN ACLIDINIUM BROMIDE INDACATEROL MALEATE SITAGLIPTIN VILANTEROL TRIFENATATE VILDAGLIPTIN CENTRAL NERVOUS SYSTEM ANTIGOUT FEBUXOSTAT DEXMETHYLPHENIDATE LESINURAD SODIUM CLOBAZAM ANTICHOLINERGIC PEDICULICIDE GLYCOPYRROLATE TOSYLATE PERMETHRIN FLUMETHRIN ANTITUSSIVE ATYPICAL ANTIPSYCHOTIC DEXTROMETHORPHAN 2020 ANESTHETIC LURASIDONE ROPIVACAINE HCl DIURETIC CHLORTHALIDONE OBER’ ANTIHISTAMINE DIETARY SUPPLEMENT DIPHENHYDRAMINE BENFOTIAMINE OCT (**) Products covered by valid patents are being developed under experimental aims in base of Art. 10(6) of Directive 2004/27/EC, exclusively directed to obtain market authorizations of our customers' generic medicines. Samples for R&D use in the United States are available as permitted under 35 USC § 271 (e) (1). Products covered by valid patents in any country are not offered or supplied to these countries when such offer constitutes a patent infringement. Tel.: +91 22 67330100 l Fax: +91 22 2652 8285 Email: [email protected] l Website: www.harmannochem.com Health.. Happiness... Harmony.... Worldwide..
Recommended publications
  • Reference List of Drugs with Potential Anticholinergic Effects 1, 2, 3, 4, 5
    ANTICHOLINERGICS: Reference List of Drugs with Potential Anticholinergic Effects 1, 2, 3, 4, 5 J Bareham BSP © www.RxFiles.ca Aug 2021 WHENEVER POSSIBLE, AVOID DRUGS WITH MODERATE TO HIGH ANTICHOLINERGIC ACTIVITY IN OLDER ADULTS (>65 YEARS OF AGE) Low Anticholinergic Activity; Moderate/High Anticholinergic Activity -B in combo Beers Antibiotics Antiparkinsonian Cardiovascular Agents Immunosuppressants ampicillin *ALL AVAILABLE AS amantadine SYMMETREL atenolol TENORMIN azaTHIOprine IMURAN cefOXitin GENERIC benztropine mesylate COGENTIN captopril CAPOTEN cyclosporine NEORAL clindamycin bromocriptine PARLODEL chlorthalidone GENERIC ONLY hydrocortisone CORTEF gentamicin (Oint & Sol’n NIHB covered) carbidopa/levodopa SINEMET digoxin LANOXIN, TOLOXIN methylprednisolone MEDROL piperacillin entacapone COMTAN dilTIAZem CARDIZEM, TIAZAC prednisone WINPRED dipyridamole PERSANTINE, ethopropazine PARSITAN vancomycin phenelzine NARDIL AGGRENOX disopyramide RYTHMODAN Muscle Relaxants pramipexole MIRAPEX Antidepressants baclofen LIORESAL ( on intrathecal only) procyclidine KEMADRIN furosemide LASIX amitriptyline ELAVIL cyclobenzaprine FLEXERIL selegiline ELDEPRYL hydrALAZINE APRESOLINE clomiPRAMINE ANAFRANIL isosorbide ISORDIL methocarbamol ROBAXIN OTC trihexyphenidyl ARTANE desipramine NORPRAMIN metoprolol LOPRESOR orphenadrine NORFLEX OTC doxepin >6mg SINEQUAN Antipsychotics NIFEdipine ADALAT tiZANidine ZANAFLEX A imipramine TOFRANIL quiNIDine GENERIC ONLY C ARIPiprazole ABILIFY & MAINTENA
    [Show full text]
  • Wednesday, July 10, 2019 4:00Pm
    Wednesday, July 10, 2019 4:00pm Oklahoma Health Care Authority 4345 N. Lincoln Blvd. Oklahoma City, OK 73105 The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Melissa Abbott, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – July 10, 2019 DATE: July 3, 2019 NOTE: The DUR Board will meet at 4:00pm. The meeting will be held at 4345 N. Lincoln Blvd. Enclosed are the following items related to the July meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Update on Medication Coverage Authorization Unit/SoonerPsych Program Update – Appendix B Action Item – Vote to Prior Authorize Jornay PM™ [Methylphenidate Extended-Release (ER) Capsule], Evekeo ODT™ [Amphetamine Orally Disintegrating Tablet (ODT)], Adhansia XR™ (Methylphenidate ER Capsule), and Sunosi™ (Solriamfetol Tablet) – Appendix C Action Item – Vote to Prior Authorize Balversa™ (Erdafitinib) – Appendix D Action Item – Vote to Prior Authorize Annovera™ (Segesterone Acetate/Ethinyl Estradiol Vaginal System), Bijuva™ (Estradiol/Progesterone Capsule), Cequa™ (Cyclosporine 0.09% Ophthalmic Solution), Corlanor® (Ivabradine Oral Solution), Crotan™ (Crotamiton 10% Lotion), Gloperba® (Colchicine Oral Solution), Glycate® (Glycopyrrolate Tablet), Khapzory™ (Levoleucovorin Injection), Qmiiz™ ODT [Meloxicam Orally Disintegrating Tablet (ODT)], Seconal Sodium™ (Secobarbital
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • JULY 2019 Mrx Pipeline a View Into Upcoming Specialty and Traditional Drugs TABLE of CONTENTS
    JULY 2019 MRx Pipeline A view into upcoming specialty and traditional drugs TABLE OF CONTENTS EDITORIAL STAFF Introduction Maryam Tabatabai, PharmD Editor in Chief Senior Director, Drug Information Pipeline Deep Dive Carole Kerzic, RPh Executive Editor Drug Information Pharmacist Keep on Your Radar Consultant Panel Michelle Booth, Pharm D Director, Medical Pharmacy Strategy Becky Borgert, PharmD, BCOP Pipeline Drug List Director, Clinical Oncology Product Development Lara Frick, PharmD, BCPS, BCPP Drug Information Pharmacist Glossary Robert Greer, RPh, BCOP Senior Director, Clinical Strategy and Programs YuQian Liu, PharmD Manager, Specialty Clinical Programs Troy Phelps Senior Director, Analytics Nothing herein is or shall be construed as a promise or representation regarding past or future events and Magellan Rx Management expressly disclaims any and all liability relating to the use of or reliance on the information contained in this presentation. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Magellan Rx Management. 1 | magellanrx.com INTRODUCTION Welcome to the MRx Pipeline. In its third year of publication, this quarterly report offers clinical insights and competitive intelligence on anticipated drugs in development. Our universal forecast addresses trends applicable across market segments. Traditional and specialty drugs, agents under the pharmacy and medical benefits, new molecular entities, pertinent new and expanded indications for existing medications, and biosimilars are profiled in the report.
    [Show full text]
  • Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: a Phase II, Randomized, Controlled, Double-Blinded Trial
    Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial Brandon Kirsch, MD,a Stacy Smith, MD,b Joel Cohen, MD,c,d Janet DuBois, MD,e Lawrence Green, MD,f Leslie Baumann, MD,g Neal Bhatia, MD,h David Pariser, MD,i Ping-Yu Liu, PhD,j Deepak Chadha, MS, MBA,a and Patricia Walker, MD, PhDa BoulderandGreenwoodVillage,Colorado;Miami,Florida;Encinitas,Irvine,andSanDiego,California; Austin, Texas; Washington, DC; Norfolk, Virginia; Seattle, Washington Background: Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options. Objective: To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide. Methods: A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting $1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with a = 0.10. Results: At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited $1-point improvement in HDSM-Ax (P \.05). Least-square mean (SE) changes in HDSM- Ax were À2.02 (0.14), À2.09 (0.14), 2.10 (0.14), and À1.30 (0.14) (all P # .0001). Most treatment-related adverse events were mild or moderate. Limitations: Not powered to detect changes in gravimetric sweat production.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • Methylnaltrexone Bromide
    含溴药物品种资料汇编 药智数据 编纂 简要说明: 本资料汇编由正文 100 页,附件 112 页构成。正文部分汇总了全部含溴药物, 包括曾经研究过、曾经上市应用、目前尚在应用以及目前尚在研的含溴药物,计 259 种。对于其中 15 种重点药物,在附件部分给出其合成方法、研发背景、药理、 药代、安全性、临床试验等方面详细的研究结果。 著录体例: 1,【别 名】,包括药物的试验编号、商标名称及其英文异名; 2,【名称来源】,指的是 WHO DI 网站上公布的推荐 INN 表和建议 INN 表, 例如,pINN-073,1995 rINN-036,1996 表示该 INN 名称来自于 1995 年的推荐 INN 第 73 表和 1996 年的建议 INN 第 36 表。 3,【中文 CADN】,指的是经国家药典委员会确定的中国药品通用名称,名 后注(97),表示该名称见于《中国药品通用名称》(1997 年版);名后注(GB4), 表示该名称见于《国家药品标准工作手册》(第四版)。 4,【建议 CADN】,指的是第 3 条中所述两书均未收录,由《药智数据》根据 INN 和 CADN 命名规律而自拟的药品中文译名。 【英文 INN】acebrochol 【别 名】acebrocol 【名称来源】pINN-001,1953 rINN-001,1955 【中文 CADN】醋溴考尔 (97) 【建议 CADN】 【化学表述】Cholestan-3-ol, 5,6-dibromo-, acetate, (3β,5α,6β)- 【CA 登记号】[514-50-1] 【分 子 式】C29H48Br2O2 【结 构 式】 【品种类别】神经系统>催眠镇静药>其它 【英文 INN】azamethonium bromide 【别 名】 【名称来源】pINN-001,1953 rINN-001,1955 【中文 CADN】阿扎溴铵(GB4) 【建议 CADN】 【化学表述】3-methyl-3-azapentane-1,5-bis(ethyl dimethyl ammonium) bromide 【CA 登记号】[306-53-6] 【分 子 式】C13H33Br2N3 【结 构 式】 【品种类别】心血管系统>抗高血压药>双季铵盐类 【英文 INN】benzpyrinium bromide 【别 名】 【名称来源】pINN-001,1953 rINN-001,1955 【中文 CADN】苄吡溴铵(GB4) 【建议 CADN】 【化学表述】Pyridinium, 1-benzyl-3-(dimethylcarbamyloxy)-, bromide 【CA 登记号】[587-46-2] 【分 子 式】C15H17BrN2O2 【结 构 式】 【品种类别】拟胆碱药 英文 INN】bibrocathol 【别 名】Noviform 【名称来源】pINN-001,1953 rINN-001,1955 【中文 CADN】铋溴酚(97) 【建议 CADN】 【化学表述】4,5,6,7-Tetrabromo-2-hydroxy-1,3,2-Benzodioxabismole 【CA 登记号】[6915-57-7] 【分 子 式】C6HBiBr4O3 【结 构 式】 【品种类别】眼科用药>消毒防腐药>其它 【英文 INN】carbromal 【别 名】 【名称来源】pINN-001,1953 rINN-001,1955 【中文 CADN】卡溴脲(97) 【建议 CADN】 【化学表述】Butanamide, N-(aminocarbonyl)-2-bromo-2-ethyl- 【CA 登记号】[77-65-6]
    [Show full text]
  • 등록특허공보(B1) (24) 등록일자 2019년03월28일
    등록특허 10-1965283 (19) 대한민국특허청(KR) (45) 공고일자 2019년04월03일 (11) 등록번호 10-1965283 (12) 등록특허공보(B1) (24) 등록일자 2019년03월28일 (51) 국제특허분류(Int. Cl.) (73) 특허권자 A61K 9/20 (2006.01) A61K 45/06 (2006.01) 트리아스텍 인코포레이티드 A61K 9/00 (2006.01) 중국 211111 지앙수 난징 피402 유 파크 이스트 (52) CPC특허분류 모져우 로드 12 A61K 9/2072 (2013.01) (72) 발명자 A61K 45/06 (2013.01) 리 샤오링 (21) 출원번호 10-2018-7035161 미국 캘리포니아 94568 더블린 발렌타노 드라이브 (22) 출원일자(국제) 2017년05월05일 2511 심사청구일자 2018년12월06일 (74) 대리인 (85) 번역문제출일자 2018년12월04일 석혜선, 김용인 (65) 공개번호 10-2018-0135975 (43) 공개일자 2018년12월21일 (86) 국제출원번호 PCT/US2017/031446 (87) 국제공개번호 WO 2017/193099 국제공개일자 2017년11월09일 (30) 우선권주장 62/332,018 2016년05월05일 미국(US) (56) 선행기술조사문헌 US19201356544 A1 US19995902605 A1 전체 청구항 수 : 총 16 항 심사관 : 김경미 (54) 발명의 명칭 제어 방출 제형 (57) 요 약 본 발명은 일반적으로 생물학적 활성제, 진단제, 시약, 화장품 및 농약/살충제의 약학적 제형 및 제어형 방출에 관한 것이다. 한 실시태양에서, 제형은 구획을 형성하는 기질을 포함하며, 기질은 적어도 제 1 조각 및 제 2 조 각을 포함하며, 제 1 조각은 제 2 조각에 작동 가능하게 연결된다. 제형은 구획 내에 적재되는 약물 내용물을 함 유한다. 제형은 또한 물 또는 체액과 접촉시 제 1 및 제 2 조각을 분리하여 구획을 개방하고 약물 내용물을 방출 할 수 있는 기질에 작동 가능하게 연결된 방출제를 포함한다. 대 표 도 - 도1b - 1 - 등록특허 10-1965283 (52) CPC특허분류 A61K 9/0095 (2013.01) A61K 9/2009 (2013.01) A61K 9/2027 (2013.01) A61K 9/2054 (2013.01) A61K 9/2095 (2013.01) - 2 - 등록특허 10-1965283 명 세 서 청구범위 청구항 1 구획을 형성하는 기질; 여기서 기질은 적어도 제 1 조각 및 제 2 조각을 포함하며, 제 1 조각은 제 2 조각에 작 동 가능하게 연결되며, 및 제 1 조각과 제 2 조각은 물과 체액을 투과하지 않으며, 구획 내에 적재되는 약물 내용물; 및 물 또는 체액과 접촉시 상기 제 1 및 제 2 조각을 분리하여 약물 내용물을 방출할 수 있는 기질에 작동 가능하 게 연결된 방출제; 를 포함하고, 여기서 구획은 방출제에 의해 밀봉되는 구멍을 가지는 것인 고체 약학적 제형.
    [Show full text]
  • A Phase 3, Multicenter, Randomized, Double-Blind
    doi: 10.1111/1346-8138.15668 Journal of Dermatology 2020; : 1–10 ORIGINAL ARTICLE A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis 1 2 3 4 Hiroo YOKOZEKI, Tomoko FUJIMOTO, Yoichiro ABE, Masaru IGARASHI, 5 6 7 8 Akiko ISHIKOH, Tokuya OMI, Hiroki KANDA, Hiroto KITAHARA, 9 10 11 12 Miwako KINOSHITA, Ichiro NAKASU, Naoko HATTORI, Yuki HORIUCHI, 13 14 15 Ryuji MARUYAMA, Haruko MIZUTANI, Yoshiyuki MURAKAMI, Chiharu Printed by[W WATANABE,16 Akihiro KUME,17 Takaaki HANAFUSA,18 Masamitsu HAMAGUCHI,19 20 21 22 23 Akira YOSHIOKA, Yuriko EGAMI, Keizo MATSUO, Tomoko MATSUDA, Motoki AKAMATSU,24 Toshiyuki YOROZUYA,24 Shinichi TAKAYAMA24 iley OnlineLibrary-073.165.017.034/doi/epdf/10.1 1Department of Dermatology, Tokyo Medical and Dental University, 2Ikebukuro Nishiguchi Fukurou Dermatology Clinic, 3Department of Pain Clinic, NTT Medical Center Tokyo, 4 Igarashi Dermatology Clinic, 5Kaminoge Hifuka Clinic, 6Department of Dermatology, Queen’s Square Medical Center, Kanagawa, 7Mita Dermatology Clinic, 8Kitahara Dermatology Clinic, 9Kinoshita Dermatology Clinic, 10Nemunoki Dermatology Clinic, Kanagawa, 11 Naoko Dermatology Clinic, 12Akihabara Skin Clinic, 13Maruyama Dermatology Clinic, 14Mizutani Dermatology Clinic, 15Mildix Skin Clinic, 16Chiharu Dermatology Clinic, Saitama, 17Dermatology and Ophthalmology Kume Clinic, Osaka, 18Senri-Chuo Hanafusa Dermatology Clinic, Osaka, 19 Hamaguchi Clinic, Osaka, 20Yoshioka Dermatology Clinic, Osaka, 21Ekihigashi Dermatology and Allergology Clinic, Fukuoka, 22 Matsuo Clinic, Fukuoka, 23Tomoko Matsuda Dermatological Clinic, Fukuoka, 24Kaken Pharmaceutical Co., Ltd., Tokyo, Japan ABSTRACT 1 A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (here- 1 inafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidro- 1/1346-8138.15668] at[23/01/2021].
    [Show full text]
  • How to Meet the Challenges of Hyperhidrosis Neal Bhatia, M.D
    How to Meet the Challenges of Hyperhidrosis Neal Bhatia, M.D. Director of Clinical Dermatology Therapeutics Clinical Research San Diego, California 2020 AOCD Spring Meeting Dr. Bhatia’s Disclosures: Affiliations with Brickell Biotech, Dermira Some slides from industry and www.sweathelp.org were borrowed for explanation of data and scientific background, not for promotion; Off-label discussion is likely Copies of pdf or questions: [email protected] Several slides borrowed from Seemal Desai, MD Learning Objectives After participating in this activity, learners will be better able to: Review the impact of HH on patient’s QOL Use appropriate tools and scales to assess severity of HH Understand the most commonly used and latest treatment approaches Discuss strategies to personalize treatment approaches Recognize the urgency of prompt treatment of HH Why do we need to sweat? Perspiration allows for thermal regulation 2 to 4 million sweat glands Temperature rises Sweating maintains cooling Physiological Triggers of Sweat: Emotions—anger, fear, anxiety Stimulants—exercise, alcohol, drugs, sex, caffeine, spicy food Stressors—Pain, Fever, Illness, Cardiac, Neurogenic Hyperhidrosis vs. Excessive Sweating Some physiologically sweat more often with triggers and stop Hyperhidrosis is a faucet that does not turn off Doolittle et al, Arch Dermatol Res, 2016; 308(10); 743-9 Primary Focal Hyperhidrosis Visible and excessive sweating, Reality--85% of pts wait >3 years >6 months duration to get evaluated No clear trigger or cause 50% wait 10+ years >70% sweat from more than one 30% pts are not diagnosed area—axillary, acral, etc. At least 2 of these criteria: Bilateral and relatively symmetric Impairs daily activities Age of onset less than 25 years Positive family history Cessation of sweating during sleep Hornberger J et al.
    [Show full text]
  • Lääkeaineiden Yleisnimet (INN-Nimet) 31.12.2019
    Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency Lääkeaineiden yleisnimet (INN-nimet) 31.12.
    [Show full text]
  • A View Into Upcoming Specialty & Traditional Drugs
    January 2020 MRx PIPELINE A VIEW INTO UPCOMING SPECIALTY & TRADITIONAL DRUGS TABLE OF CONTENTS EDITORIAL STAFF Introduction Maryam Tabatabai, PharmD Editor in Chief Senior Director, Drug Information Pipeline Deep Dive Carole Kerzic, RPh Executive Editor Drug Information Pharmacist Keep on Your Radar Consultant Panel Michelle Booth, PharmD Director, Medical Pharmacy Strategy Becky Borgert, PharmD, BCOP Pipeline Drug List Director, Clinical Oncology Product Development Lara Frick, PharmD, BCPS, BCPP Drug Information Pharmacist Glossary Robert Greer, RPh, BCOP Senior Director, Clinical Strategy and Programs Sam Leo, PharmD Director, Clinical Strategy and Innovation, Specialty Troy Phelps Senior Director, COAR - Analytics Nothing herein is or shall be construed as a promise or representation regarding past or future events and Magellan Rx Management expressly disclaims any and all liability relating to the use of or reliance on the information contained in this presentation. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Magellan Rx Management. 1 | magellanrx.com INTRODUCTION Welcome to the MRx Pipeline. In its fourth year of publication, this quarterly report offers clinical insights and competitive intelligence on anticipated drugs in development. Our universal forecast addresses trends applicable across market segments. Traditional and specialty drugs, agents under the pharmacy and medical benefits, new molecular entities, pertinent new and expanded indications for existing medications, and biosimilars are profiled in the report.
    [Show full text]