Enzon.30761.plys.qxd page 1
author: SGP3
Documents Available from the Center for Biologics Evaluation and Research page 40
author: CBER FDA
Recall of Pegaspargase, Oncaspar
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Recall of Pegaspargase, Oncaspar DATE RECALL INITIATED: June 12, 2002 LOT NUMBERS / EXPIRATION DATE: AK0129 - - 11/1/2003 AA0201 - - 1/1/2004 AE0114 - - 5/1/2003 AE0115 - - 5/1/2003 AH0120 - - 8/1/2003 MANUFACTURER: Enzon, Inc Piscataway, NJ REASON: The lots of Pegaspargase...
Recalls / Withdrawals
2003 Recall of Denileukin diftitox, Ontak - (Seragen, Inc) - 2/14/2003 2002 Recall of Infliximab, Remicade - (Centocor, Inc) - 11/19/2002 Recall of Collagenase, Santyl Ointment - (Advance Biofactures Corp) - 9/20/2002 Recall of Pegaspargase, Oncaspar - (Enzon, Inc) - 6/12/2002 2001 Recall of Interferon alfa-2b, (Recombinant), Powder for Injection, Intron A - (Schering...
Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act
IU/mL Corixa Corp License 1614 Bexxar Tositumomab and Iodine I-131 Tositumomab 125011/0 6/27/2003 Therapeutic Regimen Cytogen Corp License 1164 ProstaScint Capromab Pendetide 103608/0 10/28/1996 0.5 mg/mL Elan Pharmaceuticals License 1579 MYOBLOC Botulinum Toxin Type B 103846/0 12/8/2000 5,000 IU/mL Eli Lilly & Company License 1611 Xigris Drotrecogin alfa (Activated) 125029/0 11/21...
CBER Transfer of Therapeutic Products to CDER
Alteplase Activase Genentech, Inc Anakinra Kineret Amgen, Inc Anistreplase Eminase Wulfing Pharma GmbH Arcitumomab CEA-Scan Immunomedics, Inc Asparaginase Elspar Merck & Co., Inc Basiliximab Simulect Novartis Pharmaceuticals Corp Becaplermin Regranex OMJ Pharmaceuticals, Inc Becaplermin Concentrate - Chiron Corp Botulinum Toxin Type A BOTOX BOTOX COSMETIC Allergan, Inc Botulinum...
author: FDA / CBER
http://www.fda.gov/cder/da/ddpa94.wpd
18 473 VENTOLIN GLAXO ALBUTEROL 02 FEB 94 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.09MG/INH 27709 (LABELING REVISION PRECAUTIONS; PATIENT'S INSTRUCTIONS FOR USE) 19 548 TORNALATE STERLING WINTHROP BITOLTEROL MESYLATE 02 FEB 94 (SOLUTION) MALVERN, PA 0.2% 19355 (LABELING REVISION WARNINGS; OVERDOSAGE; DOSAGE AND ADMINISTRATION; PRECAUTIONS) 16 659 NORINYL 1+50 28 DAY SYNTEX (FP)...
Leukemia, acute lymphoblastic, childhood: Treatment - Health Professional Information [NCI PDQ] - Quest Diagnostics Patient
Leukemia, acute lymphoblastic, childhood: Treatment - Health Professional Information [NCI PDQ] This information is produced and provided by the National Cancer Institute (NCI). The treatment of this specific, rare form of ALL (B-cell ALL) is completely different than for other forms of childhood ALL. Nathan PC, Maze R, Spiegler B, et al.: CNS-directed therapy in young children...
CBER Biological Product Deviation Reporting - Non-Blood Product Codes
Poverty GU61 - Marshelder, True (Rough) GU62 - Mexican Tea GU63 - Mormon Tea GU64 - Mugwort GU65 - Mugwort, California GU66 - Mugwort, Common GU67 - Mugwort, Darkleaved GU68 - Mustard, Black GU69 - Mustard, Common Yellow GU70 - Mustard, White< br> GU71 - Nettle GU72 - Nettleleaved Goosefoot GU73 - Palmer's Amaranth GU74 - Pickleweed GU75 - Pigweed GU76 - Pigweed, Green GU77 - Pigweed...
author: CBER / FDA
Cancer.gov - Childhood Acute Lymphoblastic Leukemia (PDQ®): Treatment
Childhood Acute Lymphoblastic Leukemia (PDQ®): Treatment Two versions of this document are available For children with ALL, a number of clinical and laboratory features have demonstrated prognostic value, some of which are described below J Clin Oncol 17 (2): 445-55, 1999.A- [PUBMED Abstract] Frankel LS, Ochs J, Shuster JJ, et al.: Therapeutic trial for infant acute...
Non-Blood Product Codes: Biol Product Deviation Reporting
Poverty GU61 Marshelder, True (Rough) GU62 Mexican Tea GU63 Mormon Tea GU64 Mugwort GU65 Mugwort, California GU66 Mugwort, Common GU67 Mugwort, Darkleaved GU68 Mustard, Black GU69 Mustard, Common Yellow GU70 Mustard, White GU71 Nettle GU72 Nettleleaved Goosefoot GU73 Palmer's Amaranth GU74 Pickleweed GU75 Pigweed GU76 Pigweed, Green GU77 Pigweed, Rough Redroot GU78 Pigweed, Spiny...
author: CBER FDA
Cancer symptoms treatments - Dana-Farber Cancer Institute
Learn about cancer symptoms, treatments, detection, screening, cancer types, trials and causes at Dana-Farber. Find the cancer information on all types of cancer at the Dana-Cancer web site. ...
Dana-Farber Cancer Institute provides cancer information on all cancer types: Clinical Trials: Combination Chemotherapy in
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 ...
http://www.adis.com/files/newsletters/PT/Ptcov42.pdf
7 Pegaspargase vs asparaginase in ALL 8 Pneumococcal conjugate vaccine in daycare attendees 4 Pneumococcal vaccine in low birthweight and preterm infants 4 Protease inhibitors: poor transplacental passage 8 Risperidone vs clonidine in Tourette's syndrome 3 Salmeterol + inhaled corticosteroids relieve costs in asthma 7 Scottish experts find no link between MMR and autism 9...
http://www.adis.com/files/newsletters/INP/Icov1337.pdf
ALLERGY Loratadine recommended for approval in the US 22 CANCER Alkylating agents associated with lung cancer 21 Antineoplastics in Burkitt's lymphoma/ leukaemia 18 Antineoplastics: regimens in Hodgkin's disease 16 Asparaginase vs pegaspargase in ALL 20 Docetaxel in androgen- independent prostate cancer 12 Estramustine phosphate sodium in prostate cancer 12 Fluorouracil- based...
http://www.freseniushc.com/product/April_1_2001_Update.pdf
April 1 2001 Update Addendum A. Update of Calendar Year 2001 Hospital Outpatient Payment Rates and Coinsurance Amounts Effective April 1, 2001 National Minimum Status Relative Payment Unadjusted Unadjusted APC Group Title Indicator Weight Rate Coinsurance Coinsurance 0001 Photochemotherapy ...
http://www.freseniushc.com/product/April_1_2001_Update.pdf page 6
April 1 2001 Update 0761 Unspecified oral anti- emetic G $0.60 $0.08 $0.08 0762 Dronabinol 2.5mg oral G $3.20 $0.48 $0.48 0763 Dolasetron mesylate oral, 100 mg G $65.21 $8.74 $8.74 0764 Granisetron hcl injection 100 mcg G $1.85 $0.25 $0.25 0765 Granisetron hcl 1 mg oral G $44.70 $5.99 $5.99 0768 Ondansetron ...
FUTURE ONCOLOGY Volume 1, # 9
Volume 1, # 9 - January, 1996 Table of Contents STATE-OF-THE-ART MANAGEMENT OF CANCER LEUKEMIA AND MYELOPROLIFERATIVE/MYELODYSPLASTIC DISORDERS Epidemiology, Etiology and Classification 202 - Acute leukemia 202 - - Acute myelogenous leukemia (AML) 202 - - Acute lymphoblastic leukemia (ALL) 202 - - Adult T cell leukemia (ATL) 203 - Chronic leukemia 203 - - Chronic myelogenous leukemia...
1 Year Index (Page 1)
T E C H N O L O G Y , PR O D U C T S , MA R K E T S A N D SE R V I C E OP P O R T U N I T I E S CANCERS OF THE DIGESTIVE SYSTEM- PARTS I & II E EMIOLOGY, ETIOLOGY, PATHOGENESIS AND STAGING BY TYPE OF CANCER Esophageal Cancer 2 Stomach Cancer 3 Liver/ Biliary Cancer 4 Pancreatic Cancer 6 Gallbladder Cancer 6 Colorectal Cancer 7 Cancer of the Small Intestine 10 Anal Cancer 12 SCREENING...
author: John Himes
1 Year Index (Page 1) page 2
author: John Himes