Depocyt PN 200-063-A D#6tgd Patients with Lymphomatous Meningitis Receiving DepoCyt ® or Cytarabine (ara- C) in the Randomized Study Grade 3 or 4 All Adverse Events Adverse Events % % Number of Cycles n = 74 n = 45 n = 74 n = 45 Body System/ Adverse Event DepoCyt ® ara- C DepoCyt ® ara- C Body as a Whole 53 60 18 22 Headache* 28 9 5 2 Asthenia 19 33 5 9 Fever* 11 24 4 0...
author: Station 2
Depocyt PN 200-063-A D#6tgd page 2
author: Station 2
Depocyt PN 200-063-A D#6tgd page 1
author: Station 2
ENZON.COM : Marketed Products : DEPOCYT® Commercial Organization ABELCET® ADAGEN® DEPOCYT ® ONCASPAR® Product Pipeline Home Marketed Products DEPOCYT ® DepoCyt is a sustained release formulation of the chemotherapeutic agent, cytarabine used for the treatment of patients with lymphomatous meningitis, a complication of lymphoma that is characterized by the spread of cancer to the central...
Database D D - 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.
Drug Approvals - D NDA 20-629/S-008 10/10/02 - 10/16/03 10/16/03 Depacon (Valproate Sodium) Injection, Rx Abbott Laboratories NDA 20-593/S-006 1/24/02 1/25/02 1/25/02 Depakene Capsules, Syrup, Tablets, Sprinkle Capsules, and Depakote ER Tablets, Rx Abbott Laboratories NDA 18-081/S-038, 18-082/S-024, 18-723/S-029, 19-680/S-015, 20-593/S-009 & 21-168/S-003 12/12/02 1/29/03 Depakote ER (divalproex)...
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
../99/21-041_DepoCyt Food and Drug Administration • Center for Drug Evaluation and Research Title Search DepoCyt (Cytarabine Liposomal) Injection Company:--DepoTech Corporation Application No.:--21-041 Approval Date:-8/1/1999 Approval Letter(s) - Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) - Administrative Document(s...
author: USERNAME
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
Virginia Mason Research Center - Current Recruitments NEOPLASTIC MENIGITIS (8788) Principal Investigator: Lynne Taylor, MD Study Coordinator: Cherryl Weaver Contact Number: 1 206 223-6835 Alternate Number: 1 800 354-3527, extension 6-1814 ...
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Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
http://www.bioportfolio.com/cgi-bin/acatalog/CWEE0103-Spring'01.pdf page 19 Exit Print Contents Next Back DRUG PIPELINE NEWS 19 of 21 CenterWatchEurope · Spring 2001 Company Drug Therapeutic Area Additional Information Contact PowderJet DNA hepatitis B Phase I initiated in England +1 (888) 825- 5249 Pharmaceuticals/ immunotherapeutic GlaxoSmithKline YB BioSciences ...
CDER 1999 Report to the Nation Orphan new drug approvals Alitretinoin (Panretin), a topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi's sarcoma Bexarotene (Targretin) for treating cutaneous manifestations of cutaneous T- cell lymphoma in patients who are refractory to at least one prior systemic therapy Busulfan (Busulfex) as a preparative therapy in the treatment of malignancies with bone...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
21041LBL.PDF TABLE 1: COMPLETE RESPONSES IN PATIENTS WITH LYMPHOMATOUS MENINGITIS IN THE CONTROLLED STUDY Intent- to- treat DepoCyt Cytarabine 7/ 17 (41%) 1/ 16 (6%) INDICATIONS Depocyt is indicated for the intrathecal treatment of lymphomatous meningitis
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21041LTR.PDF NDA 21- 041 April 1, 1999 DepoTech Corporation 10450 Science Center San Diego, CA 92121 Attention: Raymond Lamy Associate Director, Regulatory Affairs Dear Mr
author: Unknown
