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(Development Pipeline) 1 Chugai Pharmaceutical Co., Ltd (Appendix 2) Development pipeline (as of February 13 th 2004) Development code Indication # Additional indication Stage (Filing date) INN Trade mark Dosage form Origin (Collaborator) Mechanism of Action Oncology CGS20267 Breast cancer in postmenopausal women Filed Jul 00 letrozole Femara TM Tablet Novartis (Novertis Pharma)...
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Investors' Information - Development Pipeline - Chugai Pharmaceutical Co., Ltd.
00 letrozole Femara TM Tablet Novartis (Novertis Pharma) Aromatase inhibitor R597 Breast cancer (adjuvant) # Phase 3 Multinational study trastuzumab Herceptin ® Injection Roche / Genentech Humanized anti-HER2 monoclonal antibody EPOCH Cancer associated anemia # Phase 2 Completed epoetin beta Epogin ® Injection In-house Recombinant human erythropoietin MRA Multiple myeloma...
http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
Reference Listed Drug Labeling Approved in November 2001
Nov 1 COREG letter ---- carvedilol tablets 20-297 S-007 INDERIDE LA letter label propranolol HCl/HCTZ extended-release capsules 19-059 S-016 INDERIDE letter label propranolol HCl/HCTZ tablets 18-031 S-030 Nov 5 TAMIFLU letter label oseltamivir phosphate suspension oseltamivir phosphate capsules 21-246 21-087 S-004 S-009 Nov 7 REGLAN letter label metoclopramide HCl...
author: USERNAME
21087_Tamiflu.htm
Food and Drug Administration Center for Drug Evaluation and Research Approval Package Search Tamiflu (Oseltamivir Phosphate) Capsule Company:- Hoffman-La Roche, Inc Application No.:- 021087 Approval Date:-10/27/99 - Approval Letter(s) - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) Part 1 - Part 2 - Statistical Review(s)...
author: Paul Stauffer
FDA Drug Approvals List November 2001
REDDY'S LABORATORIES LIMITED Active Ingredient(s): IBUPROFEN OTC/RX Status: RX Original Abbreviated Application # 075347 Approval Date: 16-NOV-01 Trade Name:OMEPRAZOLE Dosage Form: CAPSULE Applicant: ANDRX PHARMACEUTICALS, INC Active Ingredient(s): OMEPRAZOLE OTC/RX Status: RX Original Abbreviated Application # 075682 Approval Date: 14-NOV-01 Trade Name:IBU Dosage Form: TABLET...
FDA Drug Approvals List July 2001
PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE OTC...
FDA Drug Approvals List April 2002
JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): HALOPERIDOL OTC/RX Status: RX Application #: 011340 Labeling Supplement #: 016 To Original New Drug Application Approval Date: 17-APR-02 Trade Name: CERUMENEX Dosage Form: SOLUTION Applicant: PURDUE FREDERICK CO Active Ingredient(s): TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATE OTC/RX Status: OTC Application #: 010596...
Prescription and OTC Drug Product List 12/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON...
http://www.albmolecular.com/features/tekreps/vol04/no39/v04n39.pdf page 7
FDA Drug Approvals List November 2000
- Drug Approvals for November 2000 Definitions and Notes Original New Drug Applications Original Application #: 050782 Approval Date: 27-NOV-00 Trade Name: TRADENAME Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: TARGET RESEARCH ASSOCIATES Active Ingredient(s): CLINDAMYCIN PHOSPHATE OTC/RX Status: RX Indication(s): FOR ONCE A DAY TREATMENT OF ACNE...
FDA Drug Approvals List October 1999
Drug Approvals for October 1999 Definitions and Notes Original New Drug Applications Original Application #: 021087 Approval Date: 27-OCT-99 Trade Name: TAMIFLU Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: HOFFMANN LA ROCHE INC Active Ingredient(s): OSELTAMIVIR PHOSPHATE OTC/RX Status: RX Indication(s): For the treatment of uncomplicated...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Influenza: Viral Infections: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Severe Acute Respiratory Syndrome: Viral Infections: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Nabumetone to Oxytocin
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Nabumetone to Oxytocin Generic Trade Name Nabumetone RELAFEN Nadolol CORGARD Nafcillin UNIPEN Na lbuphine NUBAIN Nalidixic acid NegGRAM Naloxone NARCAN Naltrexone REVIA Nandrolone DURABOLIN Naproxen ALEVE, ANAPROX, NAPROSYN Naratriptan AMERGE Nedocromil TILADE Nefazodone SERZONE Nelfinavir VIRACEPT...
Ampligen ® Enhances the Effectiveness of Tamiflu Against Avian Influenza Second Independent Preclinical Study Confirms dsRNA
The first preclinical report, conducted by research affiliates of the National Institutes of Health at Utah State University, compared the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen® (dsRNA, Hemispherx), alone and in combination against the avian flu virus (H5N1). The researchers reported, in summary; The overall assessment is...
Hemispherx Biopharma Signs Research Agreement with Japanese National Institute of Infectious Disease Ampligen® sought as
Home - | - Corporate Info - | - R & D - | - Products - | - Investor Relations - | - For the Patient - | - Careers at Hemispherx - - Hemispherx Biopharma Press Release for Monday, October 03, 2005 Hemispherx Biopharma Signs Research Agreement with Japanese National Institute of Infectious Disease Ampligen® sought as adjuvant for nasal flu vaccine Philadelphia, PA, Monday, October...
Ampligen® Studies on Combinational Treatments Against Avian Influenza are Extended Tamiflu Resistant Strains are Reported in
The ongoing research is comparing the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen® (dsRNA, Hemispherx), alone and in combination, against the avian flu virus (H5N1). NATURE (14 October 2005), a respected science journal, reported that on February 27, 2005 an H5N1 influenza virus, A/Hanoi/30408/2005, was isolated from a 14 year old...
Oseltamivir or zanamivir for influenza (flu) - [Medication] - Quest Diagnostics Patient Health Library
Oseltamivir or zanamivir for influenza (flu) Examples Brand Name Chemical Name Relenza zanamivir Tamiflu oseltamivir phosphate Zanamivir is inhaled through a device called a Diskhaler.Oseltamivir is used to treat flu in people age 1 or older. 1 A well-controlled study found that oseltamivir, taken within 36 hours of the first flu symptoms, reduced...
Adult Health Advisor 2004.2: Influenza
Adult Health Topics | All Health Topics Find a UMHS Doctor Search Adult Topics Search All Topics This information is approved and/or reviewed by U-M Health System providers but it is not a tool for self-diagnosis or a substitute for medical treatment. Flu viruses cause more severe symptoms and can cause more severe medical problems than cold viruses. What are the symptoms?
Microsoft Word - ASX release 15 Aug - German Govt stockpiling of Relenza.doc
Biota Confirms Relenza Stockpiling in Germany Melbourne, Australia 15 August 2005. "We hope other countries will follow suit, including Australia," said Mr Molloy. The prospects of such a revival have been boosted following recent calls by scientists and health officials for active stockpiling of Relenza in addition to its competitor, Tamiflu (oseltamivir).
author: driddell