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DEPARTMENT of JUSTICE Drug Enforcement
This document is scheduled to be published in the Federal Register on 08/03/2021 and available online at DEPARTMENT OF JUSTICEfederalregister.gov/d/2021-16499, and on govinfo.gov Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation [Docket No. DEA-873] AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of application. SUMMARY: Cerilliant Corporation has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Such persons may also file a written request for a hearing on the application on or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. ADDRESS: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on June, 24, 2021, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled Substance Drug Code Schedule 3-Fluoro-N-methylcathinone -
Analysis of Synthetic Cannabinoids and Drugs of Abuse Amongst HIV-Infected Individuals
City University of New York (CUNY) CUNY Academic Works Student Theses John Jay College of Criminal Justice Fall 12-2016 Analysis of synthetic cannabinoids and drugs of abuse amongst HIV-infected individuals Jillian M. Wetzel CUNY John Jay College, [email protected] How does access to this work benefit ou?y Let us know! More information about this work at: https://academicworks.cuny.edu/jj_etds/2 Discover additional works at: https://academicworks.cuny.edu This work is made publicly available by the City University of New York (CUNY). Contact: [email protected] i Analysis of synthetic cannabinoids and drugs of abuse amongst HIV-infected individuals A thesis presented in partial fulfillment of the requirements for the degree of Master of Science in Forensic Science John Jay College of Criminal Justice City University of New York Jillian Wetzel December 2016 ii Analysis of synthetic cannabinoids and drugs of abuse amongst HIV-infected individuals Jillian Michele Wetzel This thesis has been presented to and accepted by the Office of Graduate Studies, John Jay College of Criminal Justice in partial fulfillment of the requirements for the degree of Master of Science in Forensic Science Thesis Committee: Thesis Advisor: Marta Concheiro-Guisan, Ph.D. Second Reader: Shu-Yuan Cheng, Ph.D. External Reader: Richard Curtis, Ph.D. iii Acknowledgements My greatest and sincerest gratitude goes towards my thesis advisor, professor, and mentor, Dr. Marta Concheiro-Guisan. You have educated me in more ways I thought possible and I am so thankful for all the experiences you have provided me with. As an educator you not only have taught me, but also have inspired me inside and outside the classroom. -
Effects of Levodopa on Endocannabinoid Levels in Rat Basal Ganglia: Implications for the Treatment of Levodopa-Induced Dyskinesias
European Journal of Neuroscience, Vol. 18, pp. 1607±1614, 2003 ß Federation of European Neuroscience Societies Effects of levodopa on endocannabinoid levels in rat basal ganglia: implications for the treatment of levodopa-induced dyskinesias Belen Ferrer,1 Nick Asbrock,2 Satish Kathuria,2 Daniele Piomelli2 and Andrea Giuffrida3 1Fundacion Hospital Carlos Haya, 29010 Malaga, Spain 2Department of Pharmacology, University of California at Irvine, 360 Medical Surge II, Irvine, California 92697, USA 3Department of Pharmacology, University of Texas Health Science Center, San Antonio, Texas 78229, USA Keywords: 2-arachidonylglycerol, 6-hydroxydopamine, anandamide, cannabinoid, fatty acid ethanolamides Abstract The majority of Parkinson's disease patients undergoing levodopa therapy develop disabling motor complications (dyskinesias) within 10 years of treatment. Stimulation of cannabinoid receptors, the pharmacological target of D9-tetrahydrocannabinol, is emerging as a promising therapy to alleviate levodopa-associated dyskinesias. However, the mechanisms underlying this bene®cial action remain elusive, as do the effects exerted by levodopa therapy on the endocannabinoid system. Although levodopa is known to cause changes in CB1 receptor expression in animal models of Parkinson's disease, we have no information on whether this drug alters the brain concentrations of the endocannabinoids anandamide and 2-arachidonylglycerol. To address this question, we used an isotope dilution assay to measure endocannabinoid levels in the caudate±putamen, globus pallidus and substantia nigra of intact and unilaterally 6-OHDA-lesioned rats undergoing acute or chronic treatment with levodopa (50 mg/kg). In intact animals, systemic administration of levodopa increased anandamide concentrations throughout the basal ganglia via activation of dopamine D1/D2 receptors. In 6-OHDA- lesioned rats, anandamide levels were signi®cantly reduced in the caudate±putamen ipsilateral to the lesion; however, neither acute nor chronic levodopa treatment affected endocannabinoid levels in these animals. -
Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix
United States International Trade Commission Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix USITC Publication 4208 December 2010 U.S. International Trade Commission COMMISSIONERS Deanna Tanner Okun, Chairman Irving A. Williamson, Vice Chairman Charlotte R. Lane Daniel R. Pearson Shara L. Aranoff Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement Changes to the Pharmaceutical Appendix Publication 4208 December 2010 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 15, 2010, set forth at the end of this publication, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the United States International Trade Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement changes to the Pharmaceutical Appendix, effective on January 1, 2011. Table 1 International Nonproprietary Name (INN) products proposed for addition to the Pharmaceutical Appendix to the Harmonized Tariff Schedule INN CAS Number Abagovomab 792921-10-9 Aclidinium Bromide 320345-99-1 Aderbasib 791828-58-5 Adipiplon 840486-93-3 Adoprazine 222551-17-9 Afimoxifene 68392-35-8 Aflibercept 862111-32-8 Agatolimod -
Nabilone for Chronic Pain Management: a Review of Clinical Effectiveness, Safety, and Guidelines
TITLE: Nabilone for Chronic Pain Management: A Review of Clinical Effectiveness, Safety, and Guidelines DATE: 11 November 2011 CONTEXT AND POLICY ISSUES Cannabis sativa is a flowering plant that has long been used as a recreational drug, and for medicinal purposes.1,2 The main psychoactive component of cannabis is delta-9- tetrahydrocannabinol (∆9-THC).2 Nabilone (Cesamet®) is an oral synthetic cannabinoid, which is licensed in Canada for treating patients with severe nausea and vomiting related to chemotherapy for cancer and who have failed to respond adequately to conventional antiemetic treatments.2-4 Clinical trials and anecdotal reports have suggested that the use of nabilone in other medical conditions, such as appetite stimulation, anxiety, spasticity, and pain.1,5 Chronic pain affects approximately one in five people in developed countries and two in five in less well-resourced countries. In many circumstances, the patient’s quality of life is poor due to persistent pain caused either by an ongoing illness or nerve damage caused by the disease after resolution or cure of the disease.6 Multiple sclerosis (MS) is a neurodegenerative disease, and is the most common cause of neurological disability in young people, with an average age of onset around 30 years and a prevalence of about 120 per 100,000 individuals in North America. The majority of patients with MS display symptoms, such as fatigue, muscle stiffness or spasticity, pain, memory problems, balance trouble, tremors, urinary disturbance, and sexual dysfunctions.2,7 The purpose of this review is to assess the evidence of benefits and harms related to the use of nabilone in management of chronic pain, including patients with MS. -
Federal Register/Vol. 85, No. 178/Monday, September 14, 2020
Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices 56631 agreements. All non-confidential DEPARTMENT OF JUSTICE ADDRESSES: Written comments should written submissions will be available for be sent to: Drug Enforcement public inspection at the Office of the Drug Enforcement Administration Administration, Attention: DEA Federal Secretary and on EDIS. [Docket No. DEA–713] Register Representative/DPW, 8701 The Commission vote for these Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must determinations took place on September Importer of Controlled Substances Application: Cerilliant Corporation be sent to: Drug Enforcement 8, 2020. Administration, Attn: Administrator, The authority for the Commission’s AGENCY: Drug Enforcement 8701 Morrissette Drive, Springfield, determination is contained in section Administration, Justice. Virginia 22152. All request for a hearing 337 of the Tariff Act of 1930, as ACTION: Notice of application. should also be sent to: (1) Drug amended (19 U.S.C. 1337), and in Part SUMMARY: Cerilliant Corporation has Enforcement Administration, Attn: 210 of the Commission’s Rules of applied to be registered as an importer Hearing Clerk/OALJ, 8701 Morrissette Practice and Procedure (19 CFR part of basic class(es) of controlled Drive, Springfield, Virginia 22152; and 210). substance(s). Refer to Supplemental (2) Drug Enforcement Administration, Attn: DEA Federal Register By order of the Commission. Information listed below for further Representative/DPW, 8701 Morrissette Issued: September 8, 2020. drug information. DATES: Drive, Springfield, Virginia 22152. Lisa Barton, Registered bulk manufacturers of the affected basic class(es), and SUPPLEMENTARY INFORMATION: In Secretary to the Commission. applicants therefore, may file written accordance with 21 CFR 1301.34(a), this [FR Doc. -
Recommended Methods for the Identification and Analysis of Synthetic Cannabinoid Receptor Agonists in Seized Materials (Revised and Updated)
Recommended methods for the Identification and Analysis of Synthetic Cannabinoid Receptor Agonists in Seized Materials (Revised and updated) MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES Photo credits: UNODC Photo Library; UNODC/Ioulia Kondratovitch; Alessandro Scotti. Laboratory and Scientific Section UNITED NATIONS OFFICE ON DRUGS AND CRIME Vienna Recommended Methods for the Identification and Analysis of Synthetic Cannabinoid Receptor Agonists in Seized Materials (Revised and updated) MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES UNITED NATIONS Vienna, 2020 Note Operating and experimental conditions are reproduced from the original reference materials, including unpublished methods, validated and used in selected national laboratories as per the list of references. A number of alternative conditions and substitution of named commercial products may provide comparable results in many cases, but any modification has to be validated before it is integrated into laboratory routines. Mention of names of firms and commercial products does not imply theendorsement of the United Nations. ST/NAR/48/REV.1 © United Nations, July 2020. All rights reserved, worldwide The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries. This publication has not been formally edited. Publishing production: English, Publishing and Library Section, United Nations Office at Vienna. Acknowledgements The Laboratory and Scientific Services of the United Nations Office on Drugs and Crime (UNODC) (LSS, headed by Dr. -
Problems of Drug Dependence 1980 Proceedings of the 42Nd Annual Scientific Meeting the Committee on Problems of Drug Dependence
National Institute on Drug Abuse MONOGRAPH SERIES Problems of Drug Dependence 1980 Proceedings of the 42nd Annual Scientific Meeting The Committee on Problems of Drug Dependence, Inc. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES • Public Health Service • Alcohol, Drug Abuse, and Mental Health Administration Problems of Drug Dependence, 1980 Proceedings of the 42nd Annual Scientific Meeting, The Committee on Problems of Drug Dependence, Inc. Editor: Louis S. Harris, Ph.D. NIDA Research Monograph 34 February 1981 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administration National Institute on Drug Abuse Division of Research 5600 Fishers Lane Rockville, Maryland 20857 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D.C. 20402 The NIDA Research Monograph series is prepared by the Division of Research of the National Institute on Drug Abuse. Its primary objective is to provide critical reviews of research problem areas and techniques, the content of state-of-the-art conferences, integrative research reviews and significant original research. Its dual publication emphasis is rapid and targeted dissemination to the scientific and professional community. Editorial Advisory Board Avram Goldstein, M.D. Addiction Research Foundation Palo Alto, California Jerome Jaffe, M.D. College of Physicians and Surgeons Columbia University, New York Reese T. Jones, M.D. Langley Porter Neuropsychiatric Institute University of California San Francisco, California William McGlothlin, Ph.D. Deportment of Psychology, UCLA Los Angeles, California Jack Mendelson, M.D. Alcohol and Drug Abuse Research Center Harvard Medical School McLean Hospital Belmont, Massachusetts Helen Nowlis, Ph.D. Office of Drug Education, DHHS Washington, D.C Lee Robins, Ph.D. -
Mitochondrial ADP/ATP Exchange Inhibition
www.nature.com/scientificreports OPEN Mitochondrial ADP/ATP exchange inhibition: a novel off-target mechanism underlying ibipinabant- Received: 27 March 2015 Accepted: 27 August 2015 induced myotoxicity Published: 29 September 2015 Tom J. J. Schirris1,2, Tina Ritschel3, G. Herma Renkema2,4, Peter H. G. M. Willems2,5, Jan A. M. Smeitink2,4 & Frans G. M. Russel1,2 Cannabinoid receptor 1 (CB1R) antagonists appear to be promising drugs for the treatment of obesity, however, serious side effects have hampered their clinical application. Rimonabant, the first in class CB1R antagonist, was withdrawn from the market because of psychiatric side effects. This has led to the search for more peripherally restricted CB1R antagonists, one of which is ibipinabant. However, this 3,4-diarylpyrazoline derivative showed muscle toxicity in a pre-clinical dog study with mitochondrial dysfunction. Here, we studied the molecular mechanism by which ibipinabant induces mitochondrial toxicity. We observed a strong cytotoxic potency of ibipinabant in C2C12 myoblasts. Functional characterization of mitochondria revealed increased cellular reactive oxygen species generation and a decreased ATP production capacity, without effects on the catalytic activities of mitochondrial enzyme complexes I–V or the complex specific-driven oxygen consumption. Using in silico off-target prediction modelling, combined with in vitro validation in isolated mitochondria and mitoplasts, we identified adenine nucleotide translocase (ANT)-dependent mitochondrial ADP/ATP exchange as a novel molecular mechanism underlying ibipinabant-induced toxicity. Minor structural modification of ibipinabant could abolish ANT inhibition leading to a decreased cytotoxic potency, as observed with the ibipinabant derivative CB23. Our results will be instrumental in the development of new types of safer CB1R antagonists. -
Endocannabinoids: Molecular, Pharmacological, Behavioral and Clinical Features
Endocannabinoids: Molecular, Pharmacological, Behavioral and Clinical Features Editor Eric Murillo-Rodríguez Laboratory of Molecular and Integrative Neurosciences School of Medicine, Health Sciences Division Anahuac University Mayab Merida 97310 Yucatan, Mexico Co-Editors Emmanuel S. Onaivi William Paterson University, USA Nissar A. Darmani Western University of Health Sciences, USA Edward Wagner Western University of Health Sciences, USA Bentham Science Publishers Bentham Science Publishers Bentham Science Publishers Executive Suite Y - 2 P.O. Box 446 P.O. Box 294 PO Box 7917, Saif Zone Oak Park, IL 60301-0446 1400 AG Bussum Sharjah, U.A.E. USA THE NETHERLANDS [email protected] [email protected] [email protected] Please read this license agreement carefully before using this eBook. Your use of this eBook/chapter constitutes your agreement to the terms and conditions set forth in this License Agreement. This work is protected under copyright by Bentham Science Publishers to grant the user of this eBook/chapter, a non-exclusive, nontransferable license to download and use this eBook/chapter under the following terms and conditions: 1. This eBook/chapter may be downloaded and used by one user on one computer. The user may make one back-up copy of this publication to avoid losing it. The user may not give copies of this publication to others, or make it available for others to copy or download. For a multi-user license contact [email protected] 2. All rights reserved: All content in this publication is copyrighted and Bentham Science Publishers own the copyright. You may not copy, reproduce, modify, remove, delete, augment, add to, publish, transmit, sell, resell, create derivative works from, or in any way exploit any of this publication’s content, in any form by any means, in whole or in part, without the prior written permission from Bentham Science Publishers. -
(12) Patent Application Publication (10) Pub. No.: US 2012/0022039 A1 Schwink Et Al
US 20120022039A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0022039 A1 Schwink et al. (43) Pub. Date: Jan. 26, 2012 (54) NOVEL SUBSTITUTED INDANES, METHOD Publication Classification FOR THE PRODUCTION THEREOF, AND USE (51) Int. Cl. THEREOF AS DRUGS A 6LX 3L/397 (2006.01) C07D 207/06 (2006.01) C07D 2L/22 (2006.01) C07D 22.3/04 (2006.01) (75) Inventors: Lothar Schwink, Frankfurt am C07D 22L/22 (2006.01) Main (DE); Siegfried Stengelin, C07C 235/54 (2006.01) Frankfurt am Main (DE); Matthias C07D 307/14 (2006.01) Gossel, Frankfurt am Main (DE); A63L/35 (2006.01) Klaus Wirth, Frankfurt am Main A6II 3/40 (2006.01) (DE) A6II 3/445 (2006.01) A6II 3/55 (2006.01) A63L/439 (2006.01) A6II 3/66 (2006.01) (73) Assignee: SANOFI, Paris (FR) A6II 3/34 (2006.01) A6IP3/10 (2006.01) A6IP3/04 (2006.01) A6IP3/06 (2006.01) (21) Appl. No.: 13/201410 A6IPL/I6 (2006.01) A6IP3/00 (2006.01) C07D 309/04 (2006.01) (52) U.S. Cl. .................... 514/210.01; 549/426: 548/578; (22) PCT Filed: Feb. 12, 2010 546/205; 540/484; 546/112:564/176; 549/494; 514/459:514/408: 514/319; 514/212.01; 514/299; 514/622:514/471 (86). PCT No.: PCT/EP2010/051796 (57) ABSTRACT The invention relates to substituted indanes and derivatives S371 (c)(1), thereof, to physiologically acceptable salts and physiologi (2), (4) Date: Oct. 4, 2011 cally functional derivatives thereof, to the production thereof, to drugs containing at least one substituted indane according (30) Foreign Application Priority Data to the invention or derivative thereof, and to the use of the Substituted indanes according to the invention and to deriva Feb. -
(12) United States Patent (10) Patent No.: US 9,346,762 B2 Nazare Et Al
USOO9346762B2 (12) United States Patent (10) Patent No.: US 9,346,762 B2 Nazare et al. (45) Date of Patent: May 24, 2016 (54) PYRAZOLE DERIVATIVES AND THEIR USE W 38: 28 3. A. 5.38: AS LPARSANTAGONSTS WO 2013171316 A1 11 2013 (71) Applicant: SANOFI, Paris (FR) OTHER PUBLICATIONS (72) Inventors: Marc Nazare, Frankfurt am Main (DE); Database Registry Chemical Abstracts Service, Columbus, Ohio, Detlef Kozian, Frankfurt am Main (DE); Accession No. RN 1280538-92-2, RN 1279877-48-3, RN 1279845 Andreas Evers, Frankfurt am Main 01-0, RN 1279842-08-8, RN 1279831-82-1, RN 1279830-96-4, and (DE); Werngard Czechtizky, Frankfurt RN 1279828-94-2, Entered STN: Apr. 14, 2011.* am Main (DE) Ito, Nobuyuki. Cancer Science 94(1), (2003) 3-8.* International Search Report for International Patent Application No. (73) Assignee: Sanofi, Paris (FR) PCT/EP2013/060171 dated Jun. 11, 2013 (mailed Jun. 27, 2013) p. 1-11. (*) Notice: Subject to any disclaimer, the term of this A. F. Littke et al., “Palladium-Catalyzed Coupling Reactions of Aryl Chlorides' Angew. Chem. Int. Ed. 2002, 41, 4176-4211. patent is extended or adjusted under 35 A. Padwa et al., “Reaction of Hydrazonyl Chlorides and U.S.C. 154(b) by 0 days. Carboalkoxymethylene Triphenylphosphoranes to Give 5-Alkoxy Substituted Pyrazoles' J. Heterocycl. Chem., 1987, 24, 1225-1227. (21) Appl. No.: 14/401,050 A. R. Mucietal, “Practical Palladium Catalysts for C N and C–O Bond Formation' Topics in current Chemistry 2002, 219, 131-209. (22) PCT Filed: May 16, 2013 A. Tunoori et al., “Polymer-Bound Triphenylphosphine as Traceless Reagent for Mitsunobu Reactions in Combinatorial Chemistry: Syn (86).