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Pentoxifylline - [Medication] - Quest Diagnostics Patient Health Library
Pentoxifylline Examples Brand Name Chemical Name Trental pentoxifylline How It Works Pentoxifylline increases the amount of oxygen that reaches your tissues by increasing the flexibility of your red blood cells.
Why It Is Used Pentoxifylline is used to treat intermittent claudication in people who have peripheral arterial disease (PAD).
Pentoxifylline should not be used in...
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Peripheral Arterial Disease of the Legs - Quest Diagnostics Patient Health Library
Peripheral Arterial Disease of the Legs Overview What is peripheral arterial disease of the legs?
Plaque is made up of excess cholesterol , calcium, and other substances in your bloodstream that, over time, accumulate along the inner walls of the arteries, including those that feed your legs.
1 In many people, atherosclerosis gradually develops over a lifetime, although...
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Cilostazol for peripheral arterial disease - [Medication] - Quest Diagnostics Patient Health Library
Cilostazol for peripheral arterial disease Examples Brand Name Chemical Name Pletal cilostazol How It Works Researchers do not completely understand how cilostazol relieves intermittent claudication.
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About Cilostazol for peripheral arterial...
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http://www.valentis.com/content/valentis_corp_presentation.pdf
0 Alzheimers Stroke CHF Cancer Coronary Heart Disease PAD Diabetes M i l l i o n s Am Cancer Society, Am Heart Assn, Am Diabetes Assn, Alzheimer's Disease Center ° Limited treatment options TH Surgery / balloon angioplasty ° Limited due to diffuse disease TH Trental® (Pentoxifylline) ° Limited due to efficacy issues TH Pletal® (Cilostazol) °...
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Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Announces Approval Of Cilostazol Tablets Jerusalem, Israel, November 24, 2004 - Teva Pharmaceutical Industries Ltd.
Food and Drug Administration has granted final approval for the Company’s ANDA for Cilostazol Tablets, 50 mg and 100 mg.
Teva’s Cilostazol Tablets are the AB-rated generic equivalent of...
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What's new at CDER by Date
- U.S
New and Generic Drug Approvals Curosurf (poractant alfa) Intratracheal Suspension, Dey Glyburide & Metformin Hydrochloride Tablets, Ivax Pharmaceuticals HYDREA (hydroxyurea) Capsules, Bristol-Myers Squibb Company Methergine (Methylergonovine Maleate) Tablets & Injection, Novartis M.V.I
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Genpharm Benazepril...
author: Paul Stauffer
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Drug Information
This information can be used by industry as an aid in developing drug products.- Major Drug Information Pages Accutane (Isotretinoin) Information Page Alimta (pemetrexed for injection) Information Page (2/5/2004) Analgesics: Safe Use of Over-the-Counter Pain Relievers (analgesics) and Fever Reducers (antipyretics) (1/22/2004) Avastin Information Page (2/26/2004) Baycol (cerivastatin)...
author: Carol Assouad
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Cardiovascular and Renal Drugs Advisory Committee Meetings
Topic:-- Hirulog (bivalirudin), NDA 20-873 Date:--- 7/9/98 Topic:-- Pletal (cilostazol), NDA 20-863 Date:--- 4/9/98-4/10/98 Topic:-- Aggrastat (tirofiban HCI), NDA 20-912/20-913 Topic:-- Discussion on nitric oxide Additional Documents:- Agenda, Materials , - Presentation Slides , Date:--- 1/27/98-1/28/98 Topic:--Verdia (tasosartan), NDA 20-736 Topic:-- Review and discuss...
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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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1998 Warning Letters and Untitled Letters to Pharmaceutical Companies
DMPQ 8/24 9/8 Trivora (Levonorgestrel and Ethinyl Estradiol) Tablets Watson Laboratories DDMAC 8/6 8/11 Trusopt (Dorzolamide HCL) Ophthalmic Solution Merck DDMAC 8/20 8/25 Vanceril Schering Corporation DDMAC 8/24 10/22 September Aldara (imiquimod) Cream 3M Pharmaceuticals DDMAC 9/29 11/3 Allegra (Fexofenadine HCl) Hoechst Marion Roussel DDMAC 9/23 9/28 Avapro (Irbesatan) Tablets...
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Site Index: A-F
Food and Drug Administration • Center for Drug Evaluation and Research Site Index Search CDER Index A-F 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 Adverse Reactions Adverse Events Reporting System AERS Electronic Submissions Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations How to Report Medwatch Advisory Committee and Panel Meetings Human...
author: Paul Stauffer
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Prescription and Over-the-Counter Drug Product List: 10/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
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Report to the Nation: Drug Review
Cilostazol (Pletal) is for treating stable intermittent claudication, a severe pain, aching or cramping in the legs that occurs with walking
Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix...
author: OLIVERN
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NMEs Approved in CY 1999
NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir...
author: Elaine Abraham
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Patient Information about Cilostazol
PLETAL (Cilostazol) Tablets Patient Information about PLETAL (PLAY-tal) Generic name: cilostazol (sil-OS-tah-zol) Please read this leaflet before you start taking PLETAL and each time you renew it in case anything has changed
What is PLETAL for
(See Who should not take PLETAL?) Surgery
Who should not take PLETAL
What other...
author: CDERUSERNAME
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Cilostazol Label
PLETAL ® (PLA-tal) (cilostazol) (sil-OS-tah-zol) Tablets CONTRAINDICATION Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III
DESCRIPTION PLETAL (cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III)
PLETAL (cilostazol) tablets for...
author: CDERUSERNAME
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Approval of Cilostazol
Approval of Cilostazol Introduction Cilostazol (Pletal) is a drug for the treatment of intermittent claudication
Trials of cilostazol, in contrast, with an average follow up of about 4 months, had just 19 total deaths, 12 on cilostazol, 7 on placebo, for crude rates of 0.83% cilostazol and 0.68% for placebo
Examination of the likely cause of...
author: CDERUSERNAME
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On-line Diabetes Resources: Diabetes Medications Web Sites
On-line Diabetes Resources Part 11: Diabetes Medications Web Sites By Rick Mendosa Tracking Diabetes on the Web Since February 1995 Most Recent Update: October 24, 2002 Search Mendosa.com for: This Web page ...
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Prescription and OTC Drug Product List 1/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
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Pletal Consumer Information
Pletal® Brand Name: Pletal® Active Ingredient: - cilostazol Strength(s): 50 mg and 100 mg Dosage Form(s): - Tablets Company Name: -- Otsuka America Pharmaceutical, Inc
Pletal is used to reduce the symptoms of intermittent claudication (pain in the legs that happens when walking and goes away with rest)
You must not take Pletal if you have...
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Cilostazol Information
Cilostazol Drug Information Cilostazol (Pletal) is a drug for the treatment of intermittent claudication
It allows people with this condition to exercise longer before developing their characteristic leg pain and to walk longer before they must stop because of the pain
Cilostazol’s mechanism of action is not clear
It is an inhibitor of...
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FDA Drug Approvals List- January 1999
Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
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CDER 1999 Report to the Nation
1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane ...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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CDER 1999 Report to the Nation page 12
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
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