Innovative Research & Development
- Search Tevapharm: - - Innovative Research & Development Teva has been engaged in innovative research and development for over a decade now. Furthermore, other new projects are in pre-clinical development or research phase, as can be seen in the following table: Product Indication Status Rasagiline (TVP-1012) Parkinson's Disease Submitted Valrocemide (TVP-1901) Epilepsy and other...
Database C
C - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products. Product development terminated! Approved by the FDA in September 2001 Catrix® (1496) CAV-6.1 (Candida Albicans Vaccine) (1550)...
Database G
G - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products. See Xcytrin ® (3085) Galantamine. See Insegia (2193) - Gastrostat® (3012) Gatafloxacin. Gene Activated®...
http://www.fda.gov/cder/orange/appendix_a.txt
12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE (OTC)...
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 June 2001
PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
FDA Drug Approvals List February 2001
Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Prescription and OTC Drug Product List 6/2002
45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
C:\wheelous\NDA\COPAXONE\S015apltr.doc
Controlled Trials in Patients with Multiple Sclerosis: Incidence of Glatiramer Acetate Adverse Reactions 2% and More Frequent than Placebo Glatiramer Acetate (N = 201) Placebo (N = 206) Preferred Term N % N % Body as a Whole Asthenia 83 41 78 38 Back Pain 33 16 30 15 Bacterial Infection 11 5 9 4 Chest Pain 43 21 22 11 Chills 8 4 2 1 Cyst 5 2 1 0 Face Edema 12...
author: Teresa Wheelous
Proneuron BioTechnologies
Company´s News | Media Coverage 1998-2000 | Media Coverage 2001-2002 | Media Coverage 2003-2004 Proneuron Biotechnologies and Teva Pharmaceutical Industries Sign Agreement to Develop Glatiramer Acetate for Neurological Diseases Business Editors and Health/Medical WritersGlatiramer acetate is marketed by Teva under the trade name Copaxone(R) for multiple...
FDA Drug Approvals List August 2000
Original Application #: 021197 Approval Date: 11-AUG-00 Trade Name: CETROTIDE Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: ASTA MEDICA INC Active Ingredient(s): CETRORELIX OTC/RX Status: RX Indication(s): For the prevention of premature LH surges in women undergoing controlled ovarian stimulation Original Application #: 021128 Approval Date: 01-AUG-00...
http://www.fda.gov/cder/ogd/rld/20622s9.pdf
Controlled Trials in Patients with Multiple Sclerosis: Incidence of Glatiramer Acetate Adverse eactions > 2% and More requent than Placebo Glatiramer Acetate (N = 201) Placebo (N = 206) Preferred Term N % N % Body as a Whole Asthenia 83 41 78 38 Back Pain 33 16 30 15 Bacterial Infection 11 5 9 4 Chest Pain 43 21 22 11 Chills 8 4 2 1 Cyst 5 2 1 0 Face Edema 12...
Drug Approvals December 1996
Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
Multiple Sclerosis: Multiple Sclerosis and Related Disorders: 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...
Glatiramer acetate for multiple sclerosis - [Medication] - Quest Diagnostics Patient Health Library
Glatiramer acetate for multiple sclerosis Examples Brand Name Chemical Name Copaxone glatiramer acetate How It Works Glatiramer acetate (formerly known as copolymer-1) is an artificial protein that resembles a natural myelin protein. (Drug Reference is not available in all systems.) What To Think About Glatiramer acetate may be used if you have tried...
BioPortfolio Limited
Multiple Sclerosis 5.1 Introduction 5.2 The Different Categories of MS 5.2.1 Benign MS 5.2.2 Relapse-remitting MS 5.2.3 Primary progressive MS 5.2.4 Secondary progressive 5.2.5 Progressive relapsing MS 5.3 Symptoms and Differential Diagnosis 5.3.1 Primary symptoms 5.3.2 Secondary symptoms 5.3.3 Tertiary symptoms Table 5.1 Breakdown of MS Symptoms 5.3.4 Diagnosis 5.4 The Risk factors...
Biotech Tracker News - Copaxone for Lou Gehrig Disease
Glatiramer acetate is sold as Tevas (NASDAQ: TEVA) Copaxone, currently approved for reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis. USA Voicemail and Fax:- (+1) 415 680 2472 San Francisco UK Tel:- (+44) 1300 321501 Fax: (+44) 1300 321502 -who, what, where, when and why biotechnology will impact on our lives- -...
Vaccine Research Center - Journal Publications
search --- PUBLICATIONS on this page 2003 2002 2001 2000 1999 - VRC Home Vaccine Research Center Journal Publications The NIH Library provides detailed information about online journal access and addresses frequently asked questions Nature Immunology–September 2003 Similarities and differences in CD4+ and CD8+ effector and memory T cell generation Nature 2003 Mar 20;422...
C:\wheelous\NDA\COPAXONE\S015apltr.doc page 6
author: Teresa Wheelous
C:\wheelous\NDA\COPAXONE\S015apltr.doc page 1
author: Teresa Wheelous
Case 2
Up | Previous Case | Next Case A 23 year old woman awakened one morning with marked loss of vision in her left eye and some pain and tenderness in the globe. She had previously enjoyed excellent health with ...
Proneuron BioTechnologies
Company´s News | Media Coverage 1998-2000 | Media Coverage 2001-2002 | Media Coverage 2003-2004 | Email Alerts Date: December 8, 2003 Title:Proneuron Biotechnologies Teams with Craig Hospital in Denver to Expand IND Phase II Trial of ProCord for the Treatment of Spinal Cord Injuries to the U.S Full Story Date: August 13, 2002 Title: Proneuron announces FDA approval of...
C:\wheelous\NDA\COPAXONE\S015apltr.doc page 13
author: Teresa Wheelous
C:\wheelous\NDA\COPAXONE\S015apltr.doc page 12
author: Teresa Wheelous
C:\wheelous\NDA\COPAXONE\S015apltr.doc page 11
author: Teresa Wheelous