Inex Pharmaceuticals News Releases-January 20, 2004:-INEX Signs Partnership with Enzon INEX retains manufacturing rights and will initially manufacture and supply the drug and be reimbursed by Enzon.- INEX and Enzon are discussing the potential of transferring manufacturing to Enzon’s sterile injectable manufacturing facility in Indianapolis, Indiana where Enzon manufactures its commercial drug ABELCET ® (Amphotericin B Lipid Complex...
Inex Pharmaceuticals News Releases-May 13, 2004:-INEX Releases First Quarter 2004 Operating Results News Release INEX Releases First Quarter 2004 Operating Results For immediate release: May 13, 2004 VANCOUVER - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) reported today in its first quarter 2004 operating results that achievement of two major milestones has advanced the Company toward its goals of commercializing its lead product Onco TCS and becoming a fully integrated...
http://www.enzon.com/products/abelcet/Abelcet-PI.pdf The pharmacokinetics of amphotericin B in whole blood after the administration of ABELCET ® and amphotericin B desoxycholate are: Pharmacokinetic Parameters of Amphotericin B in Whole Blood in Patients Administered Multiple Doses of ABELCET ® or Amphotericin B Desoxycholate ABELCET ® Amphotericin ...
http://www.enzon.com/products/abelcet/Abelcet-PI.pdf page 2
http://www.enzon.com/products/abelcet/Abelcet-PI.pdf page 1
ENZON.COM : Marketed Products : ABELCET® Commercial Organization ABELCET ® ADAGEN® DEPOCYT® ONCASPAR® Product Pipeline Home Marketed Products ABELCET ® ABELCET is a lipid complex formulation of amphotericin B used primarily in the hospital to treat immuno-compromised patients with invasive fungal infections.Amphotericin B, the active ingredient in ABELCET, ...
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 1
author: Reijer
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author: msulliva
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Elan: News Article 2/26/2004-08:28 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 10/2/2002 2:32:00 AM Elan to Sell North American Rights to Abelcet for $370 Million in Cash - DUBLIN, Ireland, Oct 2, 2002 (BUSINESS WIRE) -- Elan Corporation, plc (NYSE: ELN) ("Elan") has agreed to sell its United...
Elan: News Article 2/26/2004-08:28 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 10/22/2002 1:47:00 PM Publication of Elan Shareholder Circular in Connection With the Proposed Disposal of Abelcet - DUBLIN, Ireland, Oct 22, 2002 (BUSINESS WIRE) -- Elan Corporation, plc (NYSE: ELN) ("Elan") today...
Elan: News Article 2/26/2004-08:27 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 11/12/2002 6:58:00 AM Elan Receives Shareholder Approval for the Sale of Abelcet - DUBLIN, Ireland--(BUSINESS WIRE)--Nov
Elan: News Article 2/26/2004-08:27 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 11/22/2002 4:34:00 PM Elan Completes Sale of Abelcet - DUBLIN, Ireland--(BUSINESS WIRE)--Nov
Elan: News Article 2/26/2004-07:50 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 10/2/2002 2:32:00 AM Elan to Sell North American Rights to Abelcet for $370 Million in Cash - DUBLIN, Ireland, Oct 2, 2002 (BUSINESS WIRE) -- Elan Corporation, plc (NYSE: ELN) ("Elan") has agreed to sell its United...
Elan: News Article 2/26/2004-07:49 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 10/22/2002 1:47:00 PM Publication of Elan Shareholder Circular in Connection With the Proposed Disposal of Abelcet - DUBLIN, Ireland, Oct 22, 2002 (BUSINESS WIRE) -- Elan Corporation, plc (NYSE: ELN) ("Elan") today...
Elan: News Article 2/26/2004-07:49 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 11/12/2002 6:58:00 AM Elan Receives Shareholder Approval for the Sale of Abelcet - DUBLIN, Ireland--(BUSINESS WIRE)--Nov
Elan: News Article 2/26/2004-07:48 ET Site Map -|- Contact Us -|- Search:- - About Us Products Manufacturing Research & Development News Investor Relations Careers 2004 2003 2002 11/22/2002 4:34:00 PM Elan Completes Sale of Abelcet - DUBLIN, Ireland--(BUSINESS WIRE)--Nov
http://www.fda.gov/cder/orange/appendix_a.txt APPENDIX A PRODUCT NAME INDEX ** 0 ** 0, AMOXICILLIN ** 8 ** 8-HOUR BAYER, ASPIRIN (OTC) 8-MOP, METHOXSALEN ** A ** A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE A-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT A-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE A.P.L., GONADOTROPIN, CHORIONIC A/T/S, ERYTHROMYCIN ...
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
Approved Biotechnology Drugs, 2002 A --- B --- C --- D --- E --- F --- G --- H --- I --- K --- L --- M --- N --- O --- P --- R --- S --- T --- U --- V --- W --- X --- Z --- - Product (Bold text indicates recombinant and monoclonal antibody products) Company - Application (use) - Approval Date (FDA) Abelcet ® (liposomal formulation of amphotericin B) - Enzon - Treatment of invasive fungal...
http://www.fda.gov/cder/foi/label/2003/50740slr014_ambisome_lbl.pdf CLINICAL PHARMACOLOGY: Pharmacokinetics The assay used to measure amphotericin B in the serum after administration of AmBisome does not distinguish amphotericin B that is complexed with the phospholipids of AmBisome from amphotericin B that is uncomplexed
author: LINCOLNC
http://www.fda.gov/cder/foi/label/2003/50740slr014_ambisome_lbl.pdf page 9
author: LINCOLNC
