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LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library Cancer, Hormones, Men’s health, Sexual...
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LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library Cancer, Hormones, Men’s health, Sexual...
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Clinical Targets .:: Praecis Pharmaceuticals
Contact Us Site Map About Us Research Investors Careers Research Overview Technology Development Pipeline Clinical Targets - Clinical Targets - Prostate cancer Plenaxis® - United States Plenaxis® (abarelix for injectable suspension) was approved in November 2003 for marketing by the United States Food and Drug Administration.
Plenaxis® - European Union PRAECIS...
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BioPortfolio Limited
48 Antithrombotics in development for acute ischemic stroke 49 ReoPro (abciximab) 49 Retavase (reteplase) 52 Chapter 3 Alzheimer’s disease 56 Summary 56 Disease overview 57 Epidemiology 59 Market analysis 61 Aricept (donepezil) 63 Exelon (rivastigmine) 66 Reminyl (galantamine) 68 Ebixa (memantine) 70 Late-stage pipeline analysis 72 Cere (cerebrolysin) 75 COGNIShunt 77 NS-2330 79...
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BioPortfolio Limited
56 Trial size 57 Length of study 58 Clinical trial endpoints in endometriosis 59 Symptom reduction – pain 59 Improving complications – infertility 59 QoL and patient satisfaction 60 Regression of disease 60 CHAPTER 4 ENDOMETRIOSIS PIPELINE ANALYSIS 62 Pipeline overview 62 Key companies involved in the endometriosis pipeline 63 Schering AG 63 Marketed products do not target...
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Approved Products_2004.xls
194 Jul- 02 Aranes p hyperglycosylated erythropoietin Chemotherapy- induced anemia Amgen 195 Jul- 02 X yrem Sodium oxybate oral solution Cataplexy associated with narcolepsy Orphan Medical 196 Au g- 02 Prestara Prasterone Lupus Genelabs 197 Se p- 02 Hepsera Adefovir dipivoxil Chronic Hepatitus B Gilead 198 Nov- 02 Mitoz ytrex Generic mitomycin Disseminated adenocarcinoma of the...
author: Reijer
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Approved Products_2004.xls page 5
author: Reijer
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Database P
P - 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 To purchase documents on-line click on- -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
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Database A
A - 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 Coagulin-B ™ (3101) Abarelix-Depot-F (1980) Abarelix Depot-M.
See Plenaxis ™ (2249) ABP-150 (2497)...
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http://www.praecis.com/downloads/praecis2003.pdf
In November 2003, we received FDA approval to market our first product, Plenaxis (abarelix for injectable suspension), in the United States for the treatment of the symptoms of men with advanced prostate cancer for whom other hormonal therapies are not appropriate and who have refused surgical castration.
Approved Product In November 2003, we received FDA approval to...
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August 31, 2003 page 9
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August 31, 2003
Pharmacyclics Motexafin gadolinium Gadolinium texaphyrin (Gd- Tex) Phase III (completed 3/ 01) USA, Abbott Laboratories, PCI- 0120 Xcytrin that selectively accumulates in Europe metastatic brain cancer; U Texas, Hoechst Celanese cancer cells sensitizing them to phase III (begin 12/ 02) USA, radiation IV Canada, Europe, Australia lung cancer metastacized to the brain Pharmion...
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CDER: Previous News Items 2003
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items 2003 Previous News Items 2004 Previous News Items 2002 December 30, 2003 The prescribing information for Topamax (topiramate/topiramate capsules) has been revised to include a warning that Topamax causes hyperchloremic, non-anion gap metabolic acidosis (decreased serum...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
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2001 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 2001 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
11/14/2001 11/29/2001 Quadramet (Samarium Sm-153 lexidronam) injection Berlex Laboratories 11/9/2001 11/28...
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NDA Approvals for Calendar Year 2003
NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
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News Along the Pike December 2003 Issue
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - News Along the Pike January 5, 2003 Volume 9, Issue 6 Center for Drug Evaluation and Research PDF version for printouts Index Center conducts Fall Honor Awards ceremony: 62 individuals, 39 groups recognized during November event By Jackie Barber-Washington OCPB holds retreat; detailed to...
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Pharmaceutical Research and Manufacturers of America
- Praecis Pharmaceutical 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 APAN-1 none / APAN-1 Alzheimer's Disease Praecis Pharmaceutical Waltham, MA Phase I - Plenaxis none / abarelix for...
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Pharmaceutical Research and Manufacturers of America
2 relapsed or refractory - Eligard 45mg Six Month none / leuprolide acetate for injectable suspension Prostate Cancer Atrix Laboratories Fort Collins, CO Phase III palliative treatment of hormone-sensitive advanced - Estracyt HD Estracyt HD / none Prostate Cancer Pharmacia Peapack, NJ Phase I/II - Ethyol none / amifostine Breast Cancer Leukemia Lymphoma Non-Small-Cell Lung Cancer...
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Questions and Answers about Plenaxis (abarelix for injectable suspension)
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Questions and Answers about Plenaxis (abarelix for injectable suspension) What is Plenaxis and how does it work
The FDA and Praecis Pharmaceuticals, the manufacturer of Plenaxis, have worked together to create a program to ensure the safe use of Plenaxis and...
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Prescription and Over-the-Counter Drug Product List: 11/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >A> ABARELIX >A> INJECTABLE; INTRAMUSCULAR >A> PLENAXIS >A> + PRAECIS 100MG/VIAL N21320 001 NOV 25, 2003 NOV NEWA ALBUTEROL SULFATE SOLUTION; INHALATION ALBUTEROL SULFATE >A> AN BREATH LTD EQ 0.083% BASE N76370 001 NOV 24, 2003 NOV NEWA BACLOFEN TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO >D> SCHWARZ PHARMA 10MG...
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http://www.fda.gov/cder/foi/label/2003/21320_plenaxis_lbl.pdf page 28
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http://www.fda.gov/cder/foi/label/2003/21320_plenaxis_lbl.pdf page 27
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http://www.fda.gov/cder/foi/appletter/2003/21320ltr.pdf page 4
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http://www.fda.gov/cder/foi/appletter/2003/21320ltr.pdf page 2
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