Consolidated Summary of Current Treatment Modalities of Childhood Functional Abdominal Pain
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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 ........................................................................................................................ -
Research Journal of Pharmaceutical, Biological and Chemical Sciences
ISSN: 0975-8585 Research Journal of Pharmaceutical, Biological and Chemical Sciences Formulation and Evaluation of Floating Drotaverine Hydrochloride Tablets Using Factorial Design Om Prakash*, S Saraf, M Rahman, Neeraj Agnihotri, and Vinay Pathak Department of Industrial chemistry, Integral University, Lucknow. Uttar Pradesh, India. ABSTRACT The main aim of this study was to optimize and evaluate the floating tablets of Drotaverine HCl that prolong the gastric residence time, increasing drug bioavailability and control pain for longer duration by oral administration. A floating drug delivery system(FDDS) was developed using gas forming agent like sodium bicarbonate, citric acid polymers like hydroxypropyl methyl cellulose(HPMC), Sod CMC, Carbopol-934P, PVP K-30. In 32 factorial design amount of HPMC(X1) and gas generating agents(X2) were selected as independent variable and % drug release for 30min,1h, 2h,4h,6h, 8h,12h, 16h , 24h and floating lag time (FLT) were taken as dependent variable. The floating tablet formulations were evaluated for Bulk density (gm/cm3), Tapped density(gm/cm3), Hausner ratio(HR), Carr index, Angle of repose, flow property, assay, in-vitro drug release, hardness, friability,weight variation. The results of in vitro release studies showed that the optimized formulation (F9) could sustain drug release (98.74%) for 24h and remain buoyant for more than 24h. The combination of hydrophilic (HPMC) and hydrophobic (carbopol-934P) polymer provides a better option for 24h release action, bioavailability, stability of tablets at 400C/75%RH, of optimized formulation was carried for one month and no significant change was observed. Keywords: floating drug delivery system(FDDS), Drotaverine HCl, gas generating agents, floating lag time (FLT), hydrophilic (HPMC) and hydrophobic (carbopol-934P) polymer. -
Consolidated Version of the Sanpin 2.3.2.1078-01 on Food, Raw Material, and Foodstuff
Registered with the Ministry of Justice of the RF, March 22, 2002 No. 3326 MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION CHIEF STATE SANITARY INSPECTOR OF THE RUSSIAN FEDERATION RESOLUTION No. 36 November 14, 2001 ON ENACTMENT OF SANITARY RULES (as amended by Amendments No.1, approved by Resolution No. 27 of Chief State Sanitary Inspector of the RF dated 20.08.2002, Amendments and Additions No. 2, approved by Resolution No. 41 of Chief State Sanitary Inspector of the RF dated15.04.2003, No. 5, approved by Resolution No. 42 of Chief State Sanitary Inspector of the RF dated 25.06.2007, No. 6, approved by Resolution No. 13 of Chief State Sanitary Inspector of the RF dated 18.02.2008, No. 7, approved by Resolution No. 17 of Chief State Sanitary Inspector of the RF dated 05.03.2008, No. 8, approved by Resolution No. 26 of Chief State Sanitary Inspector of the RF dated 21.04.2008, No. 9, approved by Resolution No. 30 of Chief State Sanitary Inspector of the RF dated 23.05.2008, No. 10, approved by Resolution No. 43 of Chief State Sanitary Inspector of the RF dated 16.07.2008, Amendments No.11, approved by Resolution No. 56 of Chief State Sanitary Inspector of the RF dated 01.10.2008, No. 12, approved by Resolution No. 58 of Chief State Sanitary Inspector of the RF dated 10.10.2008, Amendment No. 13, approved by Resolution No. 69 of Chief State Sanitary Inspector of the RF dated 11.12.2008, Amendments No.14, approved by Resolution No. -
PMBJP Product.Pdf
Sr. Drug Generic Name of the Medicine Unit Size MRP Therapeutic Category No. Code Analgesic & Antipyretic / Muscle 1 1 Aceclofenac 100mg and Paracetamol 325 mg Tablet 10's 10's 8.00 relaxants Analgesic & Antipyretic / Muscle 2 2 Aceclofenac Tablets IP 100mg 10's 10's 4.37 relaxants Acetaminophen 325 + Tramadol Hydrochloride 37.5 film Analgesic & Antipyretic / Muscle 3 4 10's 8.00 coated Tablet 10's relaxants Analgesic & Antipyretic / Muscle 4 5 ASPIRIN Tablets IP 150 mg 14's 14's 2.70 relaxants DICLOFENAC 50 mg+ PARACETAMOL 325 mg+ Analgesic & Antipyretic / Muscle 5 6 10's 11.30 CHLORZOXAZONE 500 mg Tablets 10's relaxants Diclofenac Sodium 50mg + Serratiopeptidase 10mg Tablet Analgesic & Antipyretic / Muscle 6 8 10's 12.00 10's relaxants Analgesic & Antipyretic / Muscle 7 9 Diclofenac Sodium (SR) 100 mg Tablet 10's 10's 6.12 relaxants Analgesic & Antipyretic / Muscle 8 10 Diclofenac Sodium 25mg per ml Inj. IP 3 ml 3 ml 2.00 relaxants Analgesic & Antipyretic / Muscle 9 11 Diclofenac Sodium 50 mg Tablet 10's 10's 2.90 relaxants Analgesic & Antipyretic / Muscle 10 12 Etoricoxilb Tablets IP 120mg 10's 10's 33.00 relaxants Analgesic & Antipyretic / Muscle 11 13 Etoricoxilb Tablets IP 90mg 10's 10's 25.00 relaxants Analgesic & Antipyretic / Muscle 12 14 Ibuprofen 400 mg + Paracetamol 325 mg Tablet 10's 15's 5.50 relaxants Analgesic & Antipyretic / Muscle 13 15 Ibuprofen 200 mg film coated Tablet 10's 10's 1.80 relaxants Analgesic & Antipyretic / Muscle 14 16 Ibuprofen 400 mg film coated Tablet 10's 15's 3.50 relaxants Analgesic & Antipyretic -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE -
Minutes of PRAC Meeting on 09-12 July 2018
6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. -
(12) Patent Application Publication (10) Pub. No.: US 2014/0296.191 A1 PATEL Et Al
US 20140296.191A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0296.191 A1 PATEL et al. (43) Pub. Date: Oct. 2, 2014 (54) COMPOSITIONS OF PHARMACEUTICAL (52) U.S. Cl. ACTIVES CONTAINING DETHYLENE CPC ............... A61K 47/10 (2013.01); A61 K9/0019 GLYCOL MONOETHYLETHER OR OTHER (2013.01); A61 K9/0048 (2013.01); A61 K ALKYL DERVATIVES 45/06 (2013.01) USPC ........... 514/167: 514/177; 514/178: 514/450; (71) Applicant: THEMIS MEDICARE LIMITED, 514/334: 514/226.5: 514/449; 514/338; Mumbai (IN) 514/256; 514/570; 514/179; 514/174: 514/533; (72) Inventors: Dinesh Shantilal PATEL, Mumbai (IN); 514/629; 514/619 Sachin Dinesh PATEL, Mumbai (IN); Shashikant Prabhudas KURANI, Mumbai (IN); Madhavlal Govindlal (57) ABSTRACT PATEL, Mumbai (IN) (73) Assignee: THEMIS MEDICARE LIMITED, The present invention relates to pharmaceutical compositions Mumbai (IN) of various pharmaceutical actives, especially lyophilic and hydrophilic actives containing Diethylene glycol monoethyl (21) Appl. No.: 14/242,973 ether or other alkyl derivatives thereofas a primary vehicle and/or to pharmaceutical compositions utilizing Diethylene (22) Filed: Apr. 2, 2014 glycol monoethyl ether or other alkyl derivatives thereofas a primary vehicle or as a solvent system in preparation of Such (30) Foreign Application Priority Data pharmaceutical compositions. The pharmaceutical composi Apr. 2, 2013 (IN) ......................... 1287/MUMA2013 tions of the present invention are safe, non-toxic, exhibits enhanced physical stability compared to conventional formu Publication Classification lations containing such pharmaceutical actives and are Suit able for use as injectables for intravenous and intramuscular (51) Int. Cl. administration, as well as for use as a preformed solution/ A647/ (2006.01) liquid for filling in and preparation of capsules, tablets, nasal A6 IK 45/06 (2006.01) sprays, gargles, dermal applications, gels, topicals, liquid oral A6 IK9/00 (2006.01) dosage forms and other dosage forms. -
WO 2013/116261 A2 8 August 2013 (08.08.2013) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/116261 A2 8 August 2013 (08.08.2013) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every CUD 3/386 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US2013/023728 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 30 January 2013 (30.01 .2013) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, (26) Publication Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW. 12000745.5 3 February 2012 (03.02.2012) EP 12001034.3 16 February 2012 (16.02.2012) EP (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant: THE PROCTER & GAMBLE COMPANY GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, [US/US]; One Procter & Gamble Plaza, Cincinnati, Ohio UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 45202 (US). -
Efficacy and Safety of Drotaverine Hydrochloride in Irritable Bowel Syndrome: a Randomized Double-Blind Placebo- Controlled Study Ramesh R
Original Article Efficacy and Safety of Drotaverine Hydrochloride in Irritable Bowel Syndrome: A Randomized Double-Blind Placebo- Controlled Study Ramesh R. Rai, Manisha Dwivedi1, Nirmal Kumar2 Departments of Gastroenterology, Fortis-Escorts ABSTRACT Hospital, Jaipur, Rajasthan, 1 Gastroenterolgy, M.L.N. Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given Medical College, Allahabad, thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The 2 Uttar Pradesh, Gastroenterolgy, study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed Sri Balaji Action Medical at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of Institute, New Delhi, India 180 patients with IBS were randomized to drotaverine and placebo treatment groups. Abdominal pain and Address for correspondence: stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration. Subject Dr. Ramesh Roop Rai, H-6, Global Assessment of Relief (SGA) of IBS symptoms was assessed at the end of the study. Appropriate statistical Janpath, Shyam Nagar, analysis was done using SPSS software. Statistical Analysis Used: Mann–Whitney U-test (two-tailed), Jaipur - 302 019, Wilcoxon signed ranks test, and McNemar tests. Results: Pain frequency decreased significantly (P < 0.01) Rajasthan, India. in 22 (25.9%), 51 (60%), and 66 (77.7%) patients in the drotaverine group, at the end of 2nd, 3rd, and 4th weeks, E-mail: [email protected] respectively, as compared with 8 (9.4%), 18 (21.2%), and 26 (30.6%) in the placebo group. -
Super Greens
SUPER GREENS SUPPLEMENT FACTS Serving Size: 1 Scoop (10 g) Servings Per Container: 30 Amount Per Serving % Daily Value Calories 25 Total Carbohydrate 6 g 2%* Dietary Fiber 3 g 12%* Sugars 1 g † Protein <1 g <2%* Organic Super Greens, Sprouts & Prebiotic Fiber Blend: 3.5 g Wheat grass, barley grass, spirulina (blue green algae), green pea fiber, oat fiber, flaxseed, blue agave inulin, plum, orange peel, apple fiber, lemon peel, kale, broccoli, spinach, parsley, green cabbage, alfalfa grass, chlorella, green tea, tomato, sweet potato, pumpkin, dandelion root, collard greens, dulse, adzuki sprout, amaranth sprout, buckwheat sprout, chia sprout, flax sprout, garbanzo bean sprout, lentil bean sprout, millet sprout, pumpkin sprout, quinoa sprout, sesame sprout, sunflower sprout Organic Super Foods & Fruits Blend: 3.5 g Beet root, carrot, Organic Berry Blend [acai berry (Euterpe oleracea), apple, banana, bilberry, black currant, blueberry, cherry, elderberry, goji berry (Lycium barbarum), grape, maqui berry (Aristotelia chilensis), papaya, pineapple, pomegranate, raspberry, strawberry], apple, shitake mushroom, reishi mushroom, maitake mushroom, blueberry, raspberry, strawberry, peach, blackberry, lemon, pear, cranberry, grape, pomegranate, cherry, orange Probiotic Blend: 500 million CFU Bacillus coagulans, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus casei, Streptococcus thermophilus * Percent Daily Values are based on a 2,000 calorie diet. † Daily value not established. Other ingredients: Organic tapioca starch, organic guar gum, citric acid, organic natural berry flavor and organic rebaudioside A. . -
AFS – Advances in Food Sciences Continuation of CMTL Founded by F
AFS – Advances in Food Sciences Continuation of CMTL founded by F. Drawert Production by PSP – Parlar Scientific Publications, Angerstr. 12, 85354 Freising, Germany in cooperation with Lehrstuhl für Chemisch-Technische Analyse und Lebensmitteltechnologie, Technische Universität München, 85350 Freising - Weihenstephan, Germany Copyright © by PSP – Parlar Scientific Publications, Angerstr. 12, 85354 Freising, Germany. All rights are reserved, especially the right to translate into foreign language. No part of the journal may be reproduced in any form- through photocopying, microfilming or other processes- or converted to a machine language, especially for data processing equipment- without the written permission of the publisher. The rights of reproduction by lecture, radio and television transmission, magnetic sound recording or similar means are also reserved. Printed in GERMANY – ISSN 14311431----77377737 © by PSP Volume 24 – No 4. 2002 Advances in Food Sciences 1 © by PSP Volume 24 – No 4. 2002 Advances in Food Sciences AFSAFS---- Editorial Board Chief Editors: Prof. Dr. H. Parlar Institut für Lebensmitteltechnologie und Analytische Chemie, TU München - 85350 Freising-Weihenstephan, Germany - E-mail: [email protected] Dr. G. Leupold Institut für Lebensmitteltechnologie und Analytische Chemie, TU München - 85350 Freising-Weihenstephan, Germany - E-mail: [email protected] CoCo----Editor:Editor: Prof. Dr. R. G. Berger Zentrum Angewandte Chemie, Institut für Lebensmittelchemie, Universität Hannover Wunstorfer Straße 14, 30453 Hannover - E-mail: [email protected] AFSAFS- Advisory Board E. Anklam, I M. Bahadir, D F. Coulston, USA J.M. de Man, CAN N. Fischer, D S. Gäb, D A. Görg, D U. Gill, CAN D. Hainzl, P W.P. Hammes, D D. Kotzias, I F. -
Public Health Impact a Suitable Test for L-Citrulline—
1 Winter 2016 Public Health Impact A Suitable Test for L-citrulline— How Validated Test Methods May New Dietary Supplements Impact Public Health Reference Standards In the U.S., most newborn babies are screened for rare inborn errors of Below is a list of newly released metabolism (IEM)—a group of genetic disorders caused by a defect in a reference standards: metabolic pathway. Left untreated, these disorders can lead to a host of Botanicals medical and developmental consequences ranging from intellectual 1 disability to severe cognitive impairment and even death. • 2,3,5,4’-Tetrahydroxystilbebe-2- Some of these metabolic errors require the use of amino acids to avoid O-Beta-D-Glucoside the buildup of ammonia in the body. L-citrulline is one such amino acid, • Emodin and it is used for IEM as a medical food, which is regulated by the U.S. Food and Drug Administration (FDA) under the Orphan Drug Act. Medical • Polygonum multiflorum Root Dry foods are distinct within the broader category of foods and need to be Extract administered under the supervision of a healthcare professional • Lonicera japonica Flower Dry specifically to help manage a disease or condition associated with Extract distinctive nutritional requirements. In addition to being marketed as a medical food for IEM, L-citrulline is marketed as a dietary supplement for • Secoxyloganin other purposes. • Lonicera macranthoides Flower Sometimes, the quality control testing done to authenticate ingredients is Dry Extract insufficient to guarantee their quality. That was the case with L-citrulline in Luteolin-7-O-glucoside 2014. • One of the primary suppliers of the ingredient for use as a medical food voluntarily recalled several batches of the product after the FDA warned Non-Botanicals that the product being sold had no L-citrulline present.