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Rectal cancer: Treatment - Health Professional Information [NCI PDQ] - Quest Diagnostics Patient Health Library
Rectal cancer: Treatment - Health Professional Information [NCI PDQ] This information is produced and provided by the National Cancer Institute (NCI).
Improved survival with preoperative radiotherapy in resectable rectal cancer.
Zaheer S, Pemberton JH, Farouk R, et al.: Surgical treatment of adenocarcinoma of the rectum.
Sitzler PJ, Seow-Choen F, Ho YH, et al.: Lymph node...
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Ovarian epithelial cancer: Treatment - Health Professional Information [NCI PDQ] - Quest Diagnostics Patient Health Library
Ovarian epithelial cancer: Treatment - Health Professional Information [NCI PDQ] This information is produced and provided by the National Cancer Institute (NCI).
Stage IIIB: Macroscopic peritoneal metastasis beyond pelvis =2 cm in greatest dimension.
Trials are ongoing integrating active drugs in induction, consolidation, or maintenance regimens, added to or following initial...
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Capecitabine - [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 Capecitabine - [Medication] - Quest Diagnostics Patient Health Library Capecitabine - [Medication] - Quest Diagnostics Patient Health Library Cancer, antineoplastic agents, antineoplastic chemotherapy, Cancer Chemotherapy, Chemotherapy,...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...

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1998 Warning Letters and Untitled Letters to Pharmaceutical Companies
DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal spray Schering...
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20896s6_Xeloda (Capecitabine) Tablets
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Xeloda (Capecitabine) Tablets Company:--Roche Pharmaceuticals Application No.:--20-896/S006 & S009 Approval Date:-4/30/01 - Approval(ble) Letter(s) - Medical Review(s)/Statistical Review Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s) ...
author: Paul Stauffer
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Drug Approvals - X
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Xalatan (latanoprost) ophthalmic solution, 0.005%,- Pharmacia & Upjohn Company NDA 20-597/S28 & S29 7/14/03 7/28/03 Xalatan (latanoprost) ophthalmic solution, 0.005%,- Pharmacia & Upjohn Company NDA 20-597/S-025 8/26/02 8/30/02 8/26/02 Xalatan (latanoprost) ophthalmic solution, 0.005%,-...
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Cancer.gov - Rectal Cancer (PDQ®): Treatment
Rectal Cancer (PDQ®): Treatment Two versions of this document are available
Preoperative radiation therapy with or without chemotherapy followed by surgery with an attempt to preserve sphincter function with subsequent adjuvant chemotherapy, preferably through participation in a clinical trial.[ 22 - 24 ] Intraoperative electron beam radiation therapy (IORT) to the sites of...
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Cancer.gov - Colon Cancer (PDQ®): Treatment
J Clin Oncol 16 (11): 3537-41, 1998.A- [PUBMED Abstract] Twelves C, Boyer M, Findlay M, et al.: Capecitabine (Xeloda) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients with advanced colorectal carcinoma
Another drug, Tomudex, is a specific thymidylate synthase inhibitor which has demonstrated activity...
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News Releases 2003
For more information about the risks and uncertainties, contact the Public Relations Office 2003 In order to view the PDF files, you will need to download the Acrobat Reader - [Dec, 2003] Relocation of the West Japan Distribution Center(Chugai Distribution Co., Ltd.) (Dec 3, 2003) - [Nov, 2003] 2003 Voluntary Recall of anti-influenza drug Tamiflu® Dry Syrup 3%, Cap-Opened...
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An Increasing Number of Treatments Has Added Therapeutic Complexity
An Increasing Number of Treatments Has Added Therapeutic Complexity 0 1 2 3 4 5 6 7 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 Year Drugs Available Cituximab (Erbitux)* Bevacizumab (Avastin)* Oxaliplatin (Eloxatin) Capecitabine (Xeloda) Irinotecan/CPT-11 (Camptosar) Leucovorin (Leucovorin) 5-fluorouracil (Adrucil) *Not yet FDA approved Previous slide Next slide...
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CDER Report to the Nation: 2001
Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2001 Table of Contents 1 Drug Review Index Mission Highlights New Drug Review Standard new drugs Priority new drugs New molecular entities Standard NMEs Priority NMEs Orphan drug approvals Notable 2001 new drug approvals New or Expanded Use Review...
author: OLIVERN
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NDAs Approved under Subpart H
NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
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application notes
- OraChrom, Inc
Fast Protein Separation of STYROS™ 1R and 2R
Separation of Angiotensin Variants at Basic pH
Polymeric Hard Gel Media-HPLC vs
Fast Separation of Protein Isoforms with Fully Porous Hard Gel Media: Hemoglobins
Polymeric Gigaporous Strong Cation Exchangers: Bead Size Distribution versus Pore Size Distribution
Polymeric Gigaporous Anion Exchanger :...
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Appl. Note 25
- OraChrom, Inc
- - - - - - APPLICATION NOTE AN050202-25 Fast Detection of XELODA (Capecitabine) in Urine Sample with STYROS ™ 2R/XH
XELODA or Capecitabine is a drug with antineoplastic activity
The oncologist is presently guided by the side effects of the drug and their severity, in prescribing the optimum dosage
An alternative would have...
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Facts & News
- OraChrom, Inc
Scalability with STYROS™ columns is seamless, from a 100 mm long 4.6 mm ID columns, to a 100 mm long 10 mm ID columns of similar resolution Separation of cell culture with a 4.6 x 100 mm STYROS™ HQ/XH column- ( volume = 1.7 ml) Flow rate 5 ml/ min (1,800 cm/hr of linear velocity) - Scale up of the same separation of cell culture with a- 10 x 100 mm STYROS...
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FDA Drug Approvals List September 2001
- Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
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FDA Drug Approvals List April 2001
- Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
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FDA Drug Approvals List March 2001
Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
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Microsoft Word - e_Xeloda_f2.doc page 1


author: B00078
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http://www.chugai-pharm.co.jp/html/meeting/pdf/020130_1_booklet.pdf
rjapanj\ Investor Relations\ 020129\ NR_ booklet_ 020129_ 4
Rocaltrol Oral calcitriol 3,251 Osteoporosis, Improvement of various symptoms (hypocalcemia, numbness, tetany, paresthesia, muscle ostalgia, bone lesions, etc.) associated with vitamin D dysbolism in chronic renal failure, hypoparathyroidism, rickets/ osteomalacia Madopar levodopa + benserazide 1,599 Parkinson's disease...


duplicates:
http://www.chugai-pharm.co.jp/html/meeting/pdf/020130e_1_booklet.pdf
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http://www.chugai-pharm.co.jp/html/meeting/pdf/020130_1_booklet.pdf page 20



duplicates:
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xeloda capecitabine
Capecitabine has the following structural for ula: O OH H 3 C HO O O N N O NH F Capecitabine is a white to off- white crystalline powder with an aqueous solubility of 26 g/ L at 20º C
Bioactivation: Capecitabine is readily absorbed fro gastrointestinal tract
Absorption, Distrib tion, Metabolism and Excretion: Capecitabine reached peak blood levels...

subject: package insert labeling
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xeloda capecitabine page 18


subject: package insert labeling
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xeloda capecitabine page 16


subject: package insert labeling
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