Oncology Drugs Advisory Committee Meetings FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Oncology 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 ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
FDA Drug Approvals List March 2002 ROBBINS Active Ingredient(s): GUANFACINE HYDROCHLORIDE OTC/RX Status: RX Application #: 019991 Labeling Supplement #: 032 To Original New Drug Application Approval Date: 11-MAR-02 Trade Name: NOVOLIN 70/30 Dosage Form: INJECTABLE Applicant: NOVO NORDISK PHARMACEUTICALS INC Active Ingredient(s): INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHAN E RECOMBINANT HUMAN OTC/RX Status:...
Cyberbotanica: Camptothecin, Irinotecan Hydrochloride, and Topotecan Pharmacology of Camptothecin, Irinotecan and Topotecan [ Chemical Comparison Table | Camptotheca Page ] Camptothecin is a quinoline-based alkaloid found in the barks of the Chinese camptotheca tree and the Asian nothapodytes treetopotecan) are the only known naturally-occurring...
Prescription and OTC Drug Product List 8/1999 RTU IN PLASTIC CONTAINER - DLT - MAR 19, 1999 - ADD - AP + BAXTER HLTHCARE 500MG/100ML N18657 001 - DLT - AP + SCS 500MG/100ML N18657 001 LORACARBEF MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL LORABID CAPSULE; ORAL - ADD - KING PHARMS 200MG N50668 001 - DLT - MINOCYCLINE HCL - ADD - DEC 31, 1991 - DLT - AB WARNER CHILCOTT EQ 50MG BASE N63066 001 - ADD - + 400MG N50668 002 - DLT -...
http://www.cancercare.on.ca/formulary/pdfdrugs/topotecan.pdf Topotecan CCO Formulary Oct 2001 A DRUG NAME: TOPOTECAN SYNONYM( S): Topotecan Hydrochloride, SKF 104864 COMMON TRADE NAME( S): Hycamtin® (SmithKline Beecham) B MECHANISM OF ACTION AND PHARMACOKINETICS Topotecan is a semi- synthetic analogue of camptothecin, an agent derived from the Oriental ...
http://www.cancercare.on.ca/formulary/pdfdrugs/topotecan.pdf page 1 Topotecan CCO Formulary Oct 2001 A DRUG NAME: TOPOTECAN SYNONYM( S): Topotecan Hydrochloride, SKF 104864 COMMON TRADE NAME( S): Hycamtin® (SmithKline Beecham) B MECHANISM OF ACTION AND PHARMACOKINETICS Topotecan is a semi- synthetic analogue of camptothecin, an agent derived from the Oriental ...
FDA Drug Approvals List- November 1998 Drug Approvals for November 1998 Definitions and Notes November 1998 Original New Drug Applications Original Application #: 021008 Approval Date: 25-NOV-98 Trade Name: SANDOSTATIN LAR Chemical Type: 3 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): OCTREOTIDE ACETATE OTC/RX Status: RX...
DDPA May 1996 Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG (SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)] 16-192 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 ...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
Inex Pharmaceuticals News Releases-Nov 20, 2001:-Inex signs agreement with GlaxoSmithKline News Release Inex Pharmaceuticals Signs Agreement with GlaxoSmithKline to Develop Targeted Cancer Drugs For immediate release: Nov 20, 2001 VANCOUVER, B.C.– Inex Pharmaceuticals Corporation (-INEX-; TSE: IEX) announced today the signing of a licensing agreement with GlaxoSmithKline (GSK) to develop targeted cancer drugs that encapsulate GSK’s proprietary camptothecin...
Inex Pharmaceuticals News Releases-Mar 14, 2002:-INEX 2001 Operating Results & 2002 Milestones David Main, President and CEO, said -2001 was a year of considerable progress and we are building on this momentum in 2002 as we continue to move our products towards commercialization.- Strategic Partnerships INEX concluded a partnership in April of 2001 with Elan Corporation, plc (Elan) for the development of Onco TCS, and in November of 2001 with GlaxoSmithKline (GSK) for the...
Inex Pharmaceuticals News Releases-Jul 31, 2002:-INEX Receives Milestone Payments from GSK News Release INEX Receives Milestone Payments From Partner GlaxoSmithKline For immediate release: Jul 31, 2002 VANCOUVER, B.C.– Inex Pharmaceuticals Corporation (-INEX-; TSX: IEX) announced today it has earned US$1.5 million from GlaxoSmithKline (GSK) for achieving performance milestones related to the partnership in which the two companies are developing cancer drugs.
Inex Pharmaceuticals News Releases-Oct 31, 2002:-INEX Releases Third Quarter Results Topotecan TCS INEX and its partner GlaxoSmithKline (GSK) remain on schedule to complete toxicology studies and manufacturing requirements that would enable filing of an Investigational New Drug (IND) application for approval to begin Phase I clinical trials in 2003.Topotecan TCS comprises GSK’s approved anticancer agent, topotecan hydrochloride,...
Inex Pharmaceuticals News Releases-July 29, 2004:-INEX Releases Second Quarter Operating Results News Release INEX Releases Second Quarter Operating Results For immediate release: July 29, 2004 VANCOUVER - Inex Pharmaceuticals Corporation (INEX; TSX: IEX) reported today in its second quarter 2004 operating results the achievement of two significant milestones towards the commercialization of its lead anticancer product Onco TCS as well as progress on earlier stage products.
NeoRx Trials - Phase II Trial: Picoplatin, Small Cell Lung Home About Products Trials Investors News Room Contact Trials Phase II Trial: Picoplatin, Small Cell Lung NeoRx Trials - Phase II Trial: Picoplatin, Small Cell Lung Overview NeoRx Corporation has initiated a Phase II trial for an investigational new chemotherapy drug, picoplatin.
Cyberbotanica: Camptotheca Description and Natural History of Camptotheca Camptotheca acuminata is a member of the family Nyssaceae (tupelo family) and is native only to China and Tibet, where it is known as xi shu ("happy tree").
Cyberbotanica: Plant Compounds and Chemotherapy Welcome to Cyberbotanica, a free online botany education resource produced as a part of Indiana University's BioTech Project.
http://www.topogen.com/4100.pdf Product Application and Disclaimer This product is not licensed or approved for administration to humans or animals.Topotecan Catalog Number:...
Reviews about topoisomerases Topotecan (Hycamtin; GlaxoSmithKline; Philadelphia, PA), a topoisomerase I inhibitor, is currently approved for the treatment of patients with relapsed small cell lung cancer (SCLC) and is associated with manageable, noncumulative, hematologic toxicities.Topotecan plus gemcitabine (Gemzar; Eli Lilly and Company; Indianapolis, IN) and single-agent topotecan ...
author: M.Muller
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies Food and Drug Administration • Center for Drug Evaluation and Research Pediatrics Search Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies as of January 28, 2004 Summaries of Medical and Clinical Pharmacology Reviews Drug Sponsor Review Summary Alendronate - Fosamax Merck Medical Clinical Pharmacology Atovaquone and Proguanil - Malarone- GlaxoSmithKline...
author: CDER Office of New Drugs
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1998 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
Pharmaceutical Research and Manufacturers of America - GlaxoSmithKline Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes 2513530(GroB-T CXC chemokine) none / none GlaxoSmithKline Research Triangle Park, NC Phase I prevention of chemotherapy-induced cytopenia -...
