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Documents 1-25 out of 143 found
  Current Search:  integrilin: 818, eptifibatide: 179  

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Measuring Medication Safety.qxd page 53


author: gbon
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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...
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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...
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Millennium | Media | Press Releases | 2002 | 2002-11-11
2003 2002 Millennium Announces Initiation of Phase III Clinical Trial of Integrilin® (eptifibatide) Injection in Heart Attack Patients Cambridge, Mass., November 11, 2002 - Millennium Pharmaceuticals, Inc.
The trial, known as ADVANCE MI (ADdressing the Value of Facilitated ANgioplasty after Combination Therapy or Eptifibatide Monotherapy in Acute Myocardial...
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Millennium | Research and Development | Cardiovascular | Development Candidates | INTEGRILIN
INTEGRILIN ® Disease Overview Development Candidates Discovery Research Alliances Team DEVELOPMENT CANDIDATES INTEGRILIN ® MLN2222 INTEGRILIN® (EPTIFIBATIDE) INJECTION Millennium is investigating the potential role of INTEGRILIN beyond its currently approved indications.
INTEGRILIN is contraindicated in patients with a history of...
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14040.L.qxd page 1


author: NoemiC
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14040.L.qxd
Complex Precision Statistics (Abciximab) as Defined by NCCLS Complex Precision Within- Run Whole Blood (Simple) Total Description n n (days) (results) Mean SD CV % SD CV % Female Age 26 20 80 188.3 9.8 5.2 18.7 9.9 Female Age 41 20 80 187.0 9.1 4.9 26.1 13.9 Male Age 29 20 80 224.8 11.1 4.9 25.9 11.5 Complex Precision Statistics (Eptifibatide) as Defined by NCCLS Complex...

author: NoemiC
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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,...

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20-718_Integrilin (Eptifibatide) Injection
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Integrilin (Eptifibatide) Injection Company:--COR Therapeutics, Inc
Application No.:--20-718/S-010 & S-013 Approval Date:-6/8/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Statistical Review(s) - Clinical Pharmacology...
author: Paul Stauffer
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20718S002_Integrilin.htm
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Integrilin (Eptifibatide) Injection Company:- COR Therapeutics, Inc
Application No.:- 20-718/S-002 Approval Date:-9/20/1999 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Statistical Review(s) - Administrative Document(s) - - Back to Drug Approval Page...
author: Paul Stauffer
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20-718_Integrilin Eptifibatide Injection
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Integrilin (Eptifibatide) Injection Company:--COR Therapeutics, Inc
Application No.:--20-718 Approval Date:-5/18/1998 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 - Part 3 - Part 4 - Chemistry Review(s) - Pharmacology Review(s) Part 1 -...
author: Paul Stauffer
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http://www.accumetrics.com/uploads/GUSTOVan.pdf
Journal of Thrombosis and Thrombolysis 14( 3), 197TH 203, 2002
This treatment strategy is based on the pathophysiology of coronary thrombosis [3,4] assuming that atherosclerotic plaques contain highly thrombogenic material, that coronary thrombi are platelet- rich and that during thrombolysis potent platelet activators such as thrombin are set free leading to subsequent de novo...

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RLD LABELING APPROVED IN SEPTEMBER 1998
Reference Listed Drug Labeling Approved in September 1998 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
Firm Date PREMARIN Conjugated Estrogen Tablets 4-782 S-093 Wyeth Ayerst 08-Sep-1998 TOBI...
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FDA Drug Approvals List June 2001
Catarrhalis (including B-lactamase-producing strains) Original Application #: 021224 Approval Date: 22-JUN-01 Trade Name: REMINYL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: JANSSEN RESEARCH FDN Active Ingredient(s): GALANTAMINE HYDROBROMIDE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate dementia of the Alzheimer's type Original...
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Prescription and OTC Drug Product List 2/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...
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http://www.fda.gov/cder/foi/label/2001/20718s13lbl.pdf
Table 7 Bleeding Events and Transfusions in the PURSUIT, ESPRIT and IMPACT II Studies Placebo Eptifibatide Eptifibatide 180/ 1.3* 180/ 2.0 PURSUIT n (%) n (%) n (%) Patients 4696 1472 4679 Major bleeding a 425 (9.3%) 152 (10.5%) 498 (10.8%) Minor bleeding a 347 (7.6%) 152 (10.5%) 604 (13.1%) Requiring Transfusions b 490 (10.4%) 188 (12.8%) 601 (12.8%) Placebo ...

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http://www.fda.gov/cder/foi/label/2001/20718s13lbl.pdf page 5



duplicates:
http://www.millennium.com/images/INTEGRILIN(r)insert.pdf
http://www.corr.com/images/INTEGRILIN(r)insert.pdf
http://www.millennium.com/images/salesaid.pdf
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http://www.fda.gov/cder/foi/label/2001/20718s13lbl.pdf page 4



duplicates:
http://www.millennium.com/images/INTEGRILIN(r)insert.pdf
http://www.corr.com/images/INTEGRILIN(r)insert.pdf
http://www.millennium.com/images/salesaid.pdf
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http://www.fda.gov/cder/foi/label/2001/20718s13lbl.pdf page 3



duplicates:
http://www.millennium.com/images/INTEGRILIN(r)insert.pdf
http://www.corr.com/images/INTEGRILIN(r)insert.pdf
http://www.millennium.com/images/salesaid.pdf
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http://www.fda.gov/cder/foi/label/2001/20718s13lbl.pdf page 2


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http://www.fda.gov/cder/foi/label/2001/20718s13lbl.pdf page 1


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INTEGRILIN? (eptifibatide) INJECTION
CONFIDENTIAL Page 1 May 1, 2001 INTEGRILIN (eptifibatide) INJECTION For Intravenous Administration DESCRIPTION Eptifibatide is a cyclic heptapeptide containing six amino acids and one mercaptopropionyl (des- amino cysteinyl) residue
CONFIDENTIAL Page 21 May 1, 2001 Table 6 Major Bleeding by Maximal aPTT Within 72 Hours in the PURSUIT Study Placebo n (%) Eptifibatide...

author: AGLENN
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INTEGRILIN? (eptifibatide) INJECTION page 30


author: AGLENN
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INTEGRILIN? (eptifibatide) INJECTION page 29


author: AGLENN
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INTEGRILIN? (eptifibatide) INJECTION page 27


author: AGLENN
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