Medicines Formulary
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
The National Drugs List
^ ^ ^ ^ ^[ ^ The National Drugs List Of Syrian Arab Republic Sexth Edition 2006 ! " # "$ % &'() " # * +$, -. / & 0 /+12 3 4" 5 "$ . "$ 67"5,) 0 " /! !2 4? @ % 88 9 3: " # "$ ;+<=2 – G# H H2 I) – 6( – 65 : A B C "5 : , D )* . J!* HK"3 H"$ T ) 4 B K<) +$ LMA N O 3 4P<B &Q / RS ) H< C4VH /430 / 1988 V W* < C A GQ ") 4V / 1000 / C4VH /820 / 2001 V XX K<# C ,V /500 / 1992 V "!X V /946 / 2004 V Z < C V /914 / 2003 V ) < ] +$, [2 / ,) @# @ S%Q2 J"= [ &<\ @ +$ LMA 1 O \ . S X '( ^ & M_ `AB @ &' 3 4" + @ V= 4 )\ " : N " # "$ 6 ) G" 3Q + a C G /<"B d3: C K7 e , fM 4 Q b"$ " < $\ c"7: 5) G . HHH3Q J # Hg ' V"h 6< G* H5 !" # $%" & $' ,* ( )* + 2 ا اوا ادو +% 5 j 2 i1 6 B J' 6<X " 6"[ i2 "$ "< * i3 10 6 i4 11 6! ^ i5 13 6<X "!# * i6 15 7 G!, 6 - k 24"$d dl ?K V *4V h 63[46 ' i8 19 Adl 20 "( 2 i9 20 G Q) 6 i10 20 a 6 m[, 6 i11 21 ?K V $n i12 21 "% * i13 23 b+ 6 i14 23 oe C * i15 24 !, 2 6\ i16 25 C V pq * i17 26 ( S 6) 1, ++ &"r i19 3 +% 27 G 6 ""% i19 28 ^ Ks 2 i20 31 % Ks 2 i21 32 s * i22 35 " " * i23 37 "$ * i24 38 6" i25 39 V t h Gu* v!* 2 i26 39 ( 2 i27 40 B w< Ks 2 i28 40 d C &"r i29 42 "' 6 i30 42 " * i31 42 ":< * i32 5 ./ 0" -33 4 : ANAESTHETICS $ 1 2 -1 :GENERAL ANAESTHETICS AND OXYGEN 4 $1 2 2- ATRACURIUM BESYLATE DROPERIDOL ETHER FENTANYL HALOTHANE ISOFLURANE KETAMINE HCL NITROUS OXIDE OXYGEN PROPOFOL REMIFENTANIL SEVOFLURANE SUFENTANIL THIOPENTAL :LOCAL ANAESTHETICS !67$1 2 -5 AMYLEINE HCL=AMYLOCAINE ARTICAINE BENZOCAINE BUPIVACAINE CINCHOCAINE LIDOCAINE MEPIVACAINE OXETHAZAINE PRAMOXINE PRILOCAINE PREOPERATIVE MEDICATION & SEDATION FOR 9*: ;< " 2 -8 : : SHORT -TERM PROCEDURES ATROPINE DIAZEPAM INJ. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Tavalisse™ (Fostamatinib) (Oral) Document Number: IC-0361 Last Review Date: 02/02/2021 Date of Origin: 06/01/2018 Dates Reviewed: 06/2018, 02/2019, 02/2020, 02/2021
Tavalisse™ (fostamatinib) (Oral) Document Number: IC-0361 Last Review Date: 02/02/2021 Date of Origin: 06/01/2018 Dates Reviewed: 06/2018, 02/2019, 02/2020, 02/2021 I. Length of Authorization Coverage is provided for six months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Unit]: 100 mg tablets – 2 tablets per day 150 mg tablets – 2 tablets per day B. Max Units (per dose and over time) [HCPCS Unit]: 300 mg daily III. Initial Approval Criteria 1,2 Coverage is provided in the following conditions: Patient is at least 18 years of age; AND Universal Criteria 1 Patient is not receiving a thrombopoietin receptor agonist or mimetic (e.g., romiplostim, eltrombopag, lusutrombopag, avatrombopag, etc.); AND Laboratory values are current (i.e., drawn within the previous 28 days); AND Fostamatinib is not being used to attempt to normalize platelet count; AND Patient will avoid concomitant therapy with any of the following: o Coadministration with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, etc.), or if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented; AND o Coadministration with strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.); AND Chronic Immune Thrombocytopenia (ITP) † 1-5 Patient has had persistent/chronic ITP for at least 3 months; AND Proprietary & Confidential © 2021 Magellan Health, Inc. Patient has previously failed any of the following treatments for ITP: Patient has failed previous therapy with corticosteroids (i.e., patient had no response to at least a 3-month trial or is corticosteroid-dependent); OR Patient has failed previous therapy with immunoglobulins; OR Patient has had a splenectomy; OR Patient has failed previous therapy with a thrombopoietin receptor agonist; AND The patient is at increased risk for bleeding as indicated by platelet count of less than 30 × 109/L (30,000/mm³) † FDA Approved Indication(s) IV. -
(12) United States Patent (10) Patent No.: US 9,149,560 B2 Askari Et Al
USOO9149560B2 (12) United States Patent (10) Patent No.: US 9,149,560 B2 Askari et al. (45) Date of Patent: Oct. 6, 2015 (54) SOLID POLYGLYCOL-BASED 6,149,931 A 11/2000 Schwartz et al. BOCOMPATIBLE PRE-FORMULATION 6,153,211 A 11/2000 Hubbell et al. 6,180,687 B1 1/2001 Hammer et al. 6,207,772 B1 3/2001 Hatsuda et al. (71) Applicant: Medicus Biosciences LLC, San Jose, 6,312,725 B1 1 1/2001 Wallace et al. CA (US) 6,458,889 B1 10/2002 Trollsas et al. 6,475,508 B1 1 1/2002 Schwartz et al. (72) Inventors: Syed H. Askari, San Jose, CA (US); 6,547,714 B1 4/2003 Dailey 6,566,406 B1 5/2003 Pathak et al. Yeon S. Choi, Emeryville, CA (US); 6,605,294 B2 8/2003 Sawhney Paul Yu Jen Wan, Norco, CA (US) 6,624,245 B2 9, 2003 Wallace et al. 6,632.457 B1 10/2003 Sawhney (73) Assignee: Medicus Biosciences LLC, San Jose, 6,703,037 B1 3/2004 Hubbell et al. CA (US) 6,703,378 B1 3/2004 Kunzler et al. 6,818,018 B1 1 1/2004 Sawhney 7,009,343 B2 3/2006 Lim et al. (*) Notice: Subject to any disclaimer, the term of this 7,255,874 B1 8, 2007 Bobo et al. patent is extended or adjusted under 35 7,332,566 B2 2/2008 Pathak et al. U.S.C. 154(b) by 0 days. 7,553,810 B2 6/2009 Gong et al. -
Systematic Review of Tranexamic Acid Adverse Reactions
arm Ph ac f ov l o i a g n il r a n u c o e J Journal of Pharmacovigilance Calapai et al., J Pharmacovigilance 2015, 3:4 ISSN: 2329-6887 DOI: 10.4172/2329-6887.1000171 Review Open Access Systematic Review of Tranexamic Acid Adverse Reactions Gioacchino Calapai2*, Sebastiano Gangemi1, Carmen Mannucci2, Paola Lucia Minciullo1, Marco Casciaro1, Fabrizio Calapai3, Maria Righi4 and Michele Navarra5 1Operative Unit of Allergy and Clinical Immunology, Department of Clinical and Experimental Medicine, University of Messina, Italy 2Department of Clinical and Experimental Medicine, University of Messina, Italy 3Centro Studi Pharma.Ca, Messina, Italy 4Department of Biomedical Sciences and Morphological and Functional Images, University of Messina, Italy 5Department of Drug Sciences and Health Products, University of Messina, Italy *Corresponding author: Gioacchino Calapai, Department of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria 5, 98125 Messina, Italy, Tel: +39 090 2213646; Fax: +39 090 221; E-mail: [email protected] Received date: July 06, 2015; Accepted date: July 14, 2015; Published date: July 20, 2015 Copyright: © 2015 Calapai G, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Background Tranexamic acid is a synthetic lysine derivate that exerts its antifibrinolytic effect by reversible blocking lysine binding sites on plasminogen preventing fibrin degradation. It is widely used for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Aim The aim of our work was to review the literature regarding the best evidence on tranexamic adverse reactions and to describe them according to the apparatus involved. -
Blood Modifier Agents Policy #: Rx.01.208
Pharmacy Policy Bulletin Title: Blood Modifier Agents Policy #: Rx.01.208 Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product line, group, or contract. Some medications may be subject to precertification, age, quantity, or formulary restrictions (ie limits on non-preferred drugs). Individual member benefits must be verified. This pharmacy policy document describes the status of pharmaceutical information and/or technology at the time the document was developed. Since that time, new information relating to drug efficacy, interactions, contraindications, dosage, administration routes, safety, or FDA approval may have changed. This Pharmacy Policy will be regularly updated as scientific and medical literature becomes available. This information may include new FDA-approved indications, withdrawals, or other FDA alerts. This type of information is relevant not only when considering whether this policy should be updated, but also when applying it to current requests for coverage. Members are advised to use participating pharmacies in order to receive the highest level of benefits. Intent: The intent of this policy is to communicate the medical necessity criteria for eltrombopag olamine (Promacta®), fostamatinib disodium (Tavalisse™), avatrombopag (Doptelet®), lusutrombopag (Mulpleta®) as provided under the member's prescription drug benefit. Description: Idiopathic thrombocytopenia purpura (ITP): ITP is an immune disorder in which the blood doesn't clot normally. ITP can cause excessive bruising and bleeding and can be characterized as an unusually low level of platelets, or thrombocytes, in the blood results in ITP. Thrombocytopenia in patients with hepatitis C: Thrombocytopenia can occur in patients with chronic hepatitis C virus (HCV) infection. -
Multiple Technology Appraisal Avatrombopag and Lusutrombopag
Multiple Technology Appraisal Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Committee papers © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE MULTIPLE TECHNOLOGY APPRAISAL Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Contents: 1 Pre-meeting briefing 2 Assessment Report prepared by Kleijnen Systematic Reviews 3 Consultee and commentator comments on the Assessment Report from: • Shionogi 4 Addendum to the Assessment Report from Kleijnen Systematic Reviews 5 Company submission(s) from: • Dova • Shionogi 6 Clarification questions from AG: • Questions to Shionogi • Clarification responses from Shionogi • Questions to Dova • Clarification responses from Dova 7 Professional group, patient group and NHS organisation submissions from: • British Association for the Study of the Liver (BASL) The Royal College of Physicians supported the BASL submission • British Society of Gastroenterology (BSG) 8 Expert personal statements from: • Vanessa Hebditch – patient expert, nominated by the British Liver Trust • Dr Vickie McDonald – clinical expert, nominated by British Society for Haematology • Dr Debbie Shawcross – clinical expert, nominated by Shionogi © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. MTA: avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure Pre-meeting briefing © NICE 2019. -
Advances in Hepatology and Robley Rex VAMC NAFLD/NASH
Luis S. Marsano, MD, FAASLD, FACG, AGAF, FASGE Professor of Medicine, Director of Hepatology University of Louisville Advances in Hepatology and Robley Rex VAMC NAFLD/NASH Coagulation in Cirrhosis Topics Hepatocellular Carcinoma Miscellaneous Definitions of NAFLD, NAFL and NASH Nonalcoholic fatty liver disease (NAFLD) a. Evidence of hepatic steatosis by imaging or histology b. Lack of secondary causes of hepatic fat accumulation Non-alcoholic steato-hepatitis (NASH) Nonalcoholic fatty liver (NAFL) ≥5% hepatic steatosis and ≥5% hepatic steatosis without inflammation with hepatocyte injury evidence of hepatocellular injury in (eg, ballooning), with or without any the form of hepatocyte ballooning fibrosis Chalasani N, et al. Hepatology. 2017. doi:10.1002/hep.29367 Estimated Global Prevalence of NAFLD: 25% 24% 24% 27% 32% 13% 31% Meta-analysis: NAFLD diagnosed by imaging (US, CT, MRI/SPECT; n=45 studies). Younossi ZM, et al. Hepatology. 2016;64:73-84. 4 Estimated Global NASH Prevalence 6-7% 7-8% 5-6% 8-10% 3-4% 8-9% NASH is Prevalent Globally *25-30% of NAFLD prevalence assumed to be NASH in the above map. 5 Younossi ZM, et al. Hepatology2016;64:73-84; Williams CD, et al. Gasteoenterology 2011;140:124-131. Estimated NASH Prevalence in the U.S. ~30% of U.S. adult population Non-Alcoholic estimated to have NAFLD Fatty Liver Disease NAFLD 83.1 Million Non-Alcoholic Steatohepatitis NASH 16.5 Million Disease Spectrum Disease NASH with 3.3 Million F3/F4 Fibrosis F3 = 2 M; F4 = 1.3 M Unmet Need Estes, et al. Hepatology. 2017. doi:10.1002/hep.29466. -
Major Trauma Search Strategies Appendix
National Clinical Guidelines Centre Draft Major Trauma Search strategies appendix Clinical guideline Appendices 10 June 2015 Draft Commissioned by the National Institute for Health and Care Excellence Guideline short title Contents Disclaimer Healthcare professionals are expected to take NICE clinical guidelines fully into account when exercising their clinical judgement. However, the guidance does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient and, where appropriate, their guardian or carer. Copyright National Clinical Guideline Centre, 2015. Funding National Institute for Health and Care Excellence National Clinical Guideline Centre, 2015. Guideline short title Contents Contents Appendix A: Literature search strategies ........................................................................................ 5 National Clinical Guideline Centre, 2015. 4 <ClickGuideline this shortfield ontitle the first page and insert document title / header text> Literature search strategies Appendix A: Literature search strategies A.1 Contents Introduction Search methodology Section A.2 Standard population search strategy A.2.1 Standard major trauma population A.2.2 Haemorrhage A.2.3 Chest trauma Section A.3 Study filter terms A.3.1 Systematic reviews (SR) A.3.2 Randomised controlled trials (RCT) A.3.3 Observational studies (OBS) A.3.4 Qualitative studies (QUAL) A.3.5 Diagnostic studies (DIAG) A.3.6 Health economic studies (HE) A.3.7 Quality -
Lusutrombopag for Treating Thrombocytopenia in People with Chronic Liver Disease Needing a Planned Invasive Procedure
Lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure Technology appraisal guidance Published: 8 January 2020 www.nice.org.uk/guidance/ta617 © NICE 2020. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights). Lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure (TA617) Your responsibility The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance are at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. © NICE 2020. All rights reserved. -
WO 2014/153004 Al 25 September 2014 (25.09.2014) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization I International Bureau (10) International Publication Number (43) International Publication Date WO 2014/153004 Al 25 September 2014 (25.09.2014) P O P C T (51) International Patent Classification: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, A61L 27/58 (2006.01) A61L 27/52 (2006.01) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (21) International Application Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US20 14/028622 SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (22) International Filing Date: TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, 14 March 2014 (14.03.2014) ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (30) Priority Data: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 61/785,477 14 March 2013 (14.03.2013) US TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (71) Applicant: MEDICUS BIOSCIENCES LLC [US/US]; MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, 2528 Qume Dr., Unit #1, San Jose, CA 95 13 1 (US).