Brain tumors, adult: Treatment - Health Professional Information [NCI PDQ] - Quest Diagnostics Patient Health Library
Carmustine (BCNU)-impregnated polymer may be implanted during surgery.[ 13 , 14 ] References: Nelson DF, Nelson JS, Davis DR, et al.: Survival and prognosis of patients with astrocytoma with atypical or anaplastic features. BCNU-impregnated polymer (Gliadel wafer) implanted during initial surgery. Westphal M, Hilt DC, Bortey E, et al.: A phase 3 trial of local...
Approved Products_2004.xls
Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Approved Products_2004.xls page 2
author: Reijer
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. Cancer Vaccine (Peptide-Based) (2302) Candicidin/FR-008-Based Polyketide Analogs (2015)- Candida Albicans Vaccine (1390) Cantuzumab...
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®...
What is New
On February 25, 2003 the Food and Drug Administration (FDA) approved GLIADEL* Wafer ( Polifeprosan 20 with Carmustine Implant) as an adjunct to surgery and radiation for the treatment of patients with newly-diagnosed, high grade malignant glioma In 1996, the FDA approved GLIADEL* Wafer as an adjunct to surgery for the treatment of patients with recurrent...
author: Steve Hirschfeld
http://www.fda.gov/cder/orange/appendix_a.txt
RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
C:\Data\Products\Gliadel Wafer\Gliadel NOV 11459.doc
"Carmustine, the active component of Gliadel, can cause fetal harm when administered to a pregnant woman Hamilton addresses the complications and adverse effects of Gliadel Wafer use, only mentioning wound healing problems, infection, seizures and swelling as the side effects of Gliadel Wafer If your oncologist wanted to try you on another combination of...
author: Catherine Miller
C:\Data\Products\Gliadel Wafer\Gliadel NOV 11459.doc page 1
author: Catherine Miller
Dana-Farber Cancer Institute provides cancer information on all cancer types: Clinical Trials
Home : Cancer Information : National Clinical Trials Cancer Information by Disease What is Cancer? National Clinical Trials Cancer Prevention Screening & Detection Resources on the Web Dictionary of Medical ...
Dana-Farber Cancer Institute provides cancer information on all cancer types: Clinical Trials
Home : Cancer Information : National Clinical Trials Cancer Information by Disease What is Cancer? National Clinical Trials Cancer Prevention Screening & Detection Resources on the Web Dictionary of Medical ...
Dana-Farber Cancer Institute provides cancer information on all cancer types: Clinical Trials: Carmustine in Treating Patients
Home : Cancer Information : National Clinical Trials Cancer Information by Disease What is Cancer? National Clinical Trials Cancer Prevention Screening & Detection Resources on the Web Dictionary of Medical ...
FUTURE ONCOLOGY Volume 3 #9 January 1998
FUTURE ONCOLOGY Volume 3 #9 January 1998 State-of the-Art in the Management of Cancer Cancer of the Central Nervous System-Part II Current Therapeutic Approaches Surgery Conventional Surgery Stereotactic Radiosurgery Radiotherapy Conventional Radiation Therapy Interstitial Radiation or Brachytherapy International Isotopes Boron Neutron Capture Therapy (BNCT) Boron Biologicals...
3 Year Index (Page 1)
FUTURE ONCOLOGY VOLUME 3, NUMBER 1- 12 INDEX MAY 1998 p53 651 Introgen Therapeutics 651 Schering- Plough Research Institute 651 p16 651 Suicide Genes 651 Onyx- 015 654 Human Papillomavirus (HPV) 654 GROWTH FACTORS/ CYTOKINES 654 Epidermal Growth Factor (EGF) Receptor Inhibitors 654 Quinazolines 654 MDX- 447 655 MAb ICR62 655 Interferon as Adjuvant Therapy 655 Tumor Necrosis Factor a ...
author: John Himes
3 Year Index (Page 1) page 2
author: John Himes
Drug Approvals September 1996
Drug Approvals for September 1996 Definitions and Notes Original New Drug Applications Original Application #: 020592 Approval Date: 30-SEP-96 Trade Name: ZYPREXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: ELI LILLY AND CO Active Ingredient(s): OLANZAPINE OTC/RX Status: RX Indication(s): MANAGEMENT OF THE MANIFESTATIONS OF PSYCHOTIC DISORDERS Original...
Making a Real Difference in the Lives of Patients : MGI PHARMA
Company History Executive Team Board of Directors Strategic Alliances In Our Community Awards MGI PHARMA Biologics Aloxi® Injection Gliadel® Wafer Hexalen® Capsules Salagen® Tablets Patient Stories Dacogen Injection Saforis Oral Suspension Aquavan® Injection Aloxi® Injection (PONV) Aloxi® Oral Formulation ZYC101a GPI 1485 Irofulven MG98...
YM BioSciences Inc. Press Releases
15 Jun, 2005 YM BIOSCIENCES EXPANDS DEVELOPMENT PROGRAM FOR EGFR INHIBITOR NIMOTUZUMAB MISSISSAUGA, Canada a June 15, 2005 - YM BioSciences Inc. management, to oversee the development of nimotuzumab. - "Kuhnil has a history of relationships with Western companies dating to the mid-1970as and YM is pleased to be added to a list that has included Merck &...
Current Patents Gazette
week 0307 14 Feb 2003 Roche claims hydroxamate derivatives as histone deacetylase (HDAC) inhibitors, continuing a substantial cell proliferation inhibitor program... This is however a trivial typographical correction to the original Erratum reported here in week 0303, and ebastines final expiry date of Decemeber 12 th 2004 remains unaffected. The patent would originally...
author: Current Patents
subject: 0307
BioPortfolio Limited
Emerging Cancer Therapies, Markets and Business Opportunities TABLE OF CONTENTS Summary and Conclusions- Introduction- Historical Developments and Accomplishments Objectives of Therapy Cancer as a Chronic Disease Scope of Report Overall View of Agents in Development- Anthracyclines and Antibiotics Caelyx, Daunoxome, Myocet, Valrubicin Products in Clinical Trials Products and Projects...
Oncology Drugs Advisory Committee Meetings
Potential labeling changes and issues regarding clinical trials to address the relevant safety and efficacy concerns will be discussed; and (2) supplemental new drug application (NDA) 20-637/S016, GLIADEL Wafer (carmustine), Guilford Pharmaceuticals, Inc., indicated for use as a treatment to significantly prolong survival and maintain overall function (as measured by...
2003 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 2003 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office Click on the month to view the letters in Adobe Acrobat format Go here for further information about Adobe...
author: STAUFFERP
Drug Approval Package
Food and Drug Administration Center for Drug Evaluation and Research Approval Package Search Gliadel Wafer Company:--Guilford Pharmaceuticals Application No.:--20-637/S16 Approval Date:-2/25/2003 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Statistical Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) -...
author: USERNAME
Pharmaceutical Research and Manufacturers of America
- Guilford Pharmaceuticals 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 Gliadel Wafer Gliadel Wafer / polifeprosan 20 with carmustine impant (high dose) Malignant Glioma Guilford...
Pharmaceutical Research and Manufacturers of America
- Aventis Pharmaceuticals 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 1426 none / 1426 Obesity Aventis Pharmaceuticals Bridgewater, NJ Phase I - 3339 SERM none / 3339 SERM Osteoporosis Aventis...