Merck News Item Impressive results demonstrated across all efficacy end points The multi-center, double-blind trial showed that CANCIDAS (n=556) was as effective as AmBisome (amphotericin B) (n=539), a frequently used anti-fungal agent, in treating presumed fungal infections in neutropenic patients with persistent fever.A- The study enrolled patients who had received chemotherapy...
New Survey forecasts over 70% revenue growth in systematic antifungal market over the next decade - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
Approved Products_2004.xls Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Approved Products_2004.xls page 2
author: Reijer
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9344307 CLINICAL STUDIES Empirical Therapy in febrile, neutropenic patients A double- blind study enrolled 1111 febrile, neutropenic (< 500 cells/ mm 3 ) patients who were randomized to treatment with daily doses of CANCIDAS (50 mg/ day following a 70- mg loading dose on Day 1) or AmBisome ®1 (amphotericin B liposome for injection, 3.0 mg/ kg/ day).
Microsoft Word - Cancidas PI.doc CLINICAL STUDIES Empirical Therapy in febrile, neutropenic patients A double- blind study enrolled 1111 febrile, neutropenic (< 500 cells/ mm 3 ) patients who were randomized to treatment with daily doses of CANCIDAS (50 mg/ day following a 70- mg loading dose on Day 1) or AmBisome ®1 (amphotericin B liposome for injection, 3.0 mg/ kg/ day).
author: Cassim
Microsoft Word - Cancidas PI.doc page 12
author: Cassim
Microsoft Word - Cancidas PI.doc page 4
author: Cassim
Microsoft Word - Cancidas PI.doc page 3
author: Cassim
Amphotericin B, Streptomyces nodosus by A.G. Scientific, Biochemical Manufacturer Home > Products SEARCH: Sign In | Check Out with(milonic=new menuname("Main Menu")){ style=menuStyle; top=155; left=200; alwaysvisible=1; orientation="horizontal"; position="relative"; aI("text=---Home--url=/;status=Back To Home Page;"); aI("text=---Company--showmenu=Company;"); aI("text=---Products--showmenu=Products;"); aI("text=---Customer-Support--showmenu=CustomerSupport;"); aI(...
Drug Approvals - A This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed
Antiviral Drugs Advisory Committee Meetings FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Antiviral Drugs Advisory Committee Meetings List of Tentative Meeting Dates for All CDER Advisory Committees List of Committee Members Committee Charter CDER Contacts Current Year Meeting Information 2004 FDA Advisory Committee Calendar -Meeting information includes center, date, time and...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN ARLESHEIM, SWITZERLAND" 9552 20-Feb-92 SUMIKA FINE CHEMICALS CO LTD "DIPIVEFRIN HYDROCHLORIDE MANUFACTURED IN GIGU-PREFECTURE AND OSAKA, JAPAN." 9564 06-Mar-92 "GILEAD SCIENCES, INC." "AMBISOME, LIPOSOMAL AMPHOTERICIN B MANUFACTURED IN SAN DIMAS, CALIFORNIA." 9572 03-Mar-92 MALLINCKRODT CHEMICAL INC "NALTREXONE BASE MFG
50-740S2_AmBisome.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search AmBisome (Amphotericin B) Injection Company:--Fujisawa Healthcare, Inc
author: Paul Stauffer
50-740S001_AmBisome.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search AmBisome (Amphotericin B) Liposome Injection Company:--Fujisawa Healthcare, Incorporated Application No.:--50-740/S001 Approval Date:-1/28/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Statistical Review(s) - Clinical Pharmacology Biopharmaceutics...
author: Paul Stauffer
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf Triangle Park, NC 9 M E D I C I N E S I N D E V E L O P M E N T F O R HIV/ AIDS 2003 APPROVED MEDICINES FOR AIDS- RELATED CONDITIONS Product Name Company Indication ABELCET ® The Liposome Company treatment of severe systemic fungal infections in patients amphotericin B Princeton, NJ refractory to or intolerant of amphotericin B therapy lipid complex...
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf page 10
Mycology Workshop: Systemic Fungal Infections Amphotericin B, considered by some authorities as the -gold standard- because of its broad spectrum of activity and fungicidal action, is available only as an intravenous formulation in the United States, requiring continuous intravenous access, and is associated with significant dose-limiting toxicity, especially nephrotoxicity
Pediatric Rule Labeling Changes 463 patients 6/16/2000 AmBisome Injection (amphotericin B) -- Fujisawa Cryptococcal meningitis in HIV infected patients Escalating dose, PK study Age 1-16 yr., 47 patients New indication approved down to 1 year of age Established a dose of 6mg/kg/day 7/14/2000- * ChloraPrep OneStep OTC (chlorhexidine/ isopropyl alcohol) Medi-Flex Hospital Products Skin preparation...
author: USERNAME
Mycoses Study Group (MSG) Overview | Index | Clinical Trial Mechanisms | DAIDS Home | The Mycoses Study Group (MSG) is a self-governed organization with its own scientific agenda and process to determine what will be evaluated in its clinical trials
http://www.fda.gov/cder/foi/label/2003/50740slr014_ambisome_lbl.pdf Success rates at 2 weeks for AmBisome and amphotericin B deoxycholate are summarized in the following table: Success Rates at 2 weeks (CSF Culture Conversion) Study 94- 0- 013 AmBisome 3 mg/ kg AmBisome 6 mg/ kg Amphotericin B 0.7 mg/ kg Success at Week 2 35/ 60 (58.3%) 97.5% CI 1 = +31% 36/ 75 (48%) 97.5% CI 1 = +19.8% 29/ 61 (47.5 %) 1 97.5...
author: LINCOLNC
http://www.fda.gov/cder/foi/label/2003/50740slr014_ambisome_lbl.pdf page 33
author: LINCOLNC
