Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
Amersham plc: Annual Report & Accounts 2002 - Business at a glance: Amersham Health var pageLocation = document.URL var pageTitle = document.title separate = pageLocation.split("p-") PageNumbers = separate[1].split(".") page = PageNumbers[0] pagePrevious = page - 1 pageNext = pagePrevious + 2 function previous() { document.location = "rep-"+pagePrevious+".html" } function next() { document.location = "rep-"+pageNext+".html" } //for de-bugging //document.write("page...
Reference Listed Drug Labeling Approved in March 2000 TRADENAME ACTIVE/DOSAGE FORM NDA# SUPP# FIRM MAR DIOVAN HCT Valsartan/HCTZ/tab 20-818 S-006 Novartis Pharms 1 TIMOPTIC in OCCUDOSE Timolol maleate/opth.sol 19-463 S-020 Merck 2 EFFEXOR Venlafaxine HCl 20-151 S-014 Wyeth Ayerst 3 EFFEXOR XR Venlafaxine HCl 20-699 S-008 Wyeth Ayerst 3 TECZEM Diltiazem malate/enalapril maleate 20-507 S-002 Aventis Pharms 3 PROPULSID Cisapride/oral sol...
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 6/2003 4 >D> + ROBINS AH 325MG;60MG N84446 001 JUN DISC >A> @ 325MG;60MG N84446 001 JUN DISC ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX >A> @ DURAMED PHARM BARR 500MG N12945 001 JUN CAHN >A> + 500MG N12945 003 APR 25, 1995 JUN CAHN >D> @ LEDERLE 500MG N12945 001 JUN CAHN >D> + 500MG N12945 003 APR 25, 1995 JUN CAHN TABLET; ORAL >A> AB DURAMED PHARM BARR 125MG N08943 001 JUN CAHN ...
author: AUTHOR
http://www.nycomed-amersham.com/investors/AR02/AR2002.pdf Performance 2002 Sales Opera ing profi R& D expendi ure Employees £948 million, £256 million, £95 million, 5, 300 up 8% up 9% up 14% Key products Optison, ( human albumin microspheres containing perflutren) The leading ultrasound product for the emerging market of contrast- enhanced ultrasound, for visualising the orders of the heart muscle
C:\Data\My Documents\CMC Supplements\NDA20899\letters\SCM007APLTR.\ DOC page 1
author: Patricia Stewart
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock itch)...
cpmp_pr_1150_98.PDF The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html 29 June 1998 CPMP/ 1150/ 98 ...
author: WELLS
cpmp_pr_1150_98.PDF page 6 CPMP/ 1150/ 981 6/ 17 OPTISON International Non- proprietary Name (INN): Octafluoropropane Abstract * On 18 May 1998, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Optison, which contains octafluoropropane. This Decision ...
author: WELLS
Drug Approvals for December 1997 Drug Approvals for December 1997 Definitions and Notes December 1997 Original New Drug Applications Original Application #: 020899 Approval Date: 31-DEC-97 Trade Name: OPTISON Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: MOLECULAR BIOSYSTEMS, INCHUMAN ALBUMIN MICROSPHERES OTC/RX Status: RX Indication(s): For...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LOUIS, MO." 12873 22-Feb-98 HUIZHOU DONGJIANG PHARMACEUTICAL FACTORY GUANGDONG "CLOZAPINE, USP, MANUFACTURED IN GUANGDONG PROVINCE, CHINA." 12874 23-Feb-98 REPLIGEN CORP "IMMOBILIZED PROTEIN A IPA-400HC, MANUFACTURED IN NEEDHAM, MASSACHUSETTS." 12876 23-Feb-98 INDENA SPA "PACLITAXEL, MANUFACTURED IN SETTALA (MI)- ITALY" 12879 26-Feb-98 ROQUETTE FRERES SA "MANNITOL USP GRADE,...
Amersham plc Annual Report & Accounts 2001: Chief Executive's review - continued The life science market in 2001 offered both challenges and opportunities, following the completion of the draft sequence of the human genomehuman genome in 2000 marked a milestone in achievement, but this is just the beginning of genomics and its related fields
Amersham plc Annual Report & Accounts 2001: Chief Executive's review - continued - - - Dr John Padfield Chief Executive, Amersham Health Amersham Health Amersham Health is a world leader in medical diagnostic pharmaceutical products for the early and accurate diagnosis of disease, and a major provider of therapy products for the treatment of cancer
Amersham plc Annual Report & Accounts 2001: Chief Executive's review - - - Business review Amersham made impressive gains in 2001, as the breadth of our innovative technologies and our strong brands enabled us to sustain good growth across both of our businesses
Amersham plc: Annual Report & Accounts 2002 - Chief Executive's review (continued) var pageLocation = document.URL var pageTitle = document.title separate = pageLocation.split("p-") PageNumbers = separate[1].split(".") page = PageNumbers[0] pagePrevious = page - 1 pageNext = pagePrevious + 2 function previous() { document.location = "rep-"+pagePrevious+".html" } function next() { document.location = "rep-"+pageNext+".html" } //for de-bugging //document.write("page...
Amersham plc: Amersham Health Fast facts Medical diagnostics - 55% of total Amersham sales Diagnostic imaging agents used in medical scanning procedures to highlight organs, tissues and cells inside the human body, for the early detection, diagnosis and management of disease
http://www.nycomed-amersham.com/investors/amersham-20-F.pdf page 34
http://www.nycomed-amersham.com/about/fastfacts03/ff27-5-03.pdf Executive management Sir William Castell, Chief Executive Giles Kerr, Finance Director Robin Freestone, Financial Controller Peter Loescher, President Amersham Health Dr Andrew Carr, President discover stems, Amersham Biosciences Peter Ehrenheim, President protein separations, Amersham Biosciences George Battersb , Human Resources Director Dr L nne Gaile , Director of Corporate...
http://www.nycomed-amersham.com/about/fastfacts03/ff27-5-03.pdf page 2
Office of Device Evaluation Annual Report Fiscal Year 2000 Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health - - - - Acknowledgements Thanks to the following organizations for their invaluable assistance in preparing this report: ODE Program Operations Staff ODE Review Divisions ODE Program Management Office OSM Division of Planning, Analysis and...
author: ODE
Medicinal Products with a Community Marketing authorisation - Status October 2002 List The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit Medicinal Products with a Community Marketing authorisation Status: October 2002 Product Brandname INN Part A/ B Company Name Origin Therapeutic Area ATC Indication Presentation Form Strengths Number ...
author: EMEA
subject: List
Microsoft Word - esps00000.doc MBI was the developer of Optison ® , the only intravenous ultrasound contrast agent being marketed in both the UOptison with Mallinckrodt, a unit of Tyco Healthcare, and Nycomed Amersham plc, and from a partnership with Chugai Pharmaceutical Co., Ltd., which is developing Optison ...
http://www.nycomed-amersham.com/investors/IR02/ir02.pdf 1 1 Interim Report & ccounts 2002 Amersham plc More questions more answers Contents More questions, more answers Sir William Castell 02 Dr John Padfield 04 Dr Andrew Carr 06 Interim Report & Accounts Financial overview 08 Dividend calendar 10 Group profit and loss account 11 Group balance sheet 12 Group cash flow statement 13 Statement of total recognised gains and losses 14 Note of...
SONUS PHARMACEUTICALS ANNOUNCES DEVELOPMENT OF NEW CARDIOVASCULAR DRUG DELIVERY PRODUCT “We have achieved several important objectives since implementing our new business strategy, and we are encouraged and excited about the progress that we are making.” S-8184 – Cancer Therapy “Sonus recently met an important milestone with the initiation of a Phase 1 human clinical study with our cancer therapeutic product, S-8184, a paclitaxel emulsion...
