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
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.
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,...
1997 Warning Letters and Notice of Violation 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 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information OfficeDaunoXome (daunorubicin citrate liposome injection) Nexstar...
Prescription and OTC Drug Product List 6/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N65033 001 - DLT - FEB...
DDPA July 1995 19-971 DEXTROSE 5% DHL DEXTROSE 06-JUL-95 IN PLASTIC CONTAINER UNION, SC 5GM/100ML (INJECTABLE) 29379 (FLUID AND NUTRIENT REPLENISHER) 50-704 DAUNOXOME VESTAR LIPOSOMAL DAUNORUBICIN 10-JUL-95 (INJECTABLE) SAN DIMAS, CA CITRATE 91773 EQ 2MG BASE/ML (ANTINEOPLASTIC) [PRIMARY THERAPY FOR THE PALLIATIVE MANAGEMENT OF ADVANCED, HIV-ASSOCIATED KAPOSI'S SARCOMA] 20-372...
DDPA April 1996 Drug and Device Product Approvals for April 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-537 CIPRO BAYER CIPROFLOXACIN HYDROCHLORIDE 08-APR-96 (TABLET) WEST HAVEN, CT EQ 100MG BASE (SUPPL-026) 06516 EQ 250MG BASE EQ 500MG BASE EQ 750MG BASE (NEW INDICATION -- TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES) 20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE 08-APR...
TRIAL Protocol / Clinical Study In order for our site to display correctly you will need a newer version of your web browser.daunorubicin with FLAG will be...
author: St. Jude Children's Research Hospital
http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0247.pdf week 0247 22 Nov 2002 Abbott seems to be claiming its first small molecule P2X3 purinoceptor inhibitors with a range of new 1-naphthylenyl]benzamides...
Gazette Highlights News 2002 - Thomson Scientific Thomson.com - - - - - Advanced Search - - - EN : JP : CN : KR -- - - Thomson Scientific : Gazette Weekly Highlights News : Gazette Highlights News 2002 - Gazette Highlights News 2002 Click on a week to view more Week 52: We wish all readers a happy and successful New Year!DaunoXome (a liposomal formulation of daunorubicin) was...
Approved Products_2004.xls page 2
author: Reijer
Drug Approvals - D ANDA 75-371 8/27/99 9/2/99 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Gensia Sicor Pharmaceuticals ANDA 75-259 8/27/98 9/2/98 - - Dalmane (flurazepam hydrochloride) Capsules, 15 mg and 30 mg ICN Pharmaceuticals NDA 16-721/S-074 6/14/01 11/22/02 Daraprim (pyrimethamine) Tablets, 25 mg, Rx GlaxoSmithKline NDA 8-578/S16 11/18/03 11/25/03 12/1/03 - Daraprim (pyrimethamine)...
Cancer.gov - Nausea and Vomiting (PDQ®) The American Society of Clinical Oncology (ASCO) has developed a rating system for chemotherapeutic agents and their respective risk of acute and delayed emesis.[ 1 ] High-risk cisplatin: Emesis that has been documented to occur in more than 99% of patients: cisplatin (Platinol) High-risk noncisplatin: Emesis that has been documented to occur in 30% to greater than 90% of patients:...
ASCO/FDA Lung Cancer Endpoints Workshop: Final Summary FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER American Society of Clinical Oncology/FDA Lung Cancer Endpoints Workshop April 15, 2003 [The following comments reflect the opinions of the workshop participants and do not necessarily represent the views of the FDA] Introductory Remarks Dr
ASCO/FDA Lung Cancer Endpoints Workshop 4/15/03 CDER USER ASCO/FDA Lung Cancer Endpoints Workshop 4/15/03 _ * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * - o * * o * * o * * o * * o * * o * - o * * o * * o * 12/9/2003 ASCO/FDA Lung Cancer Endpoints Workshop DRAFT 10/8/03 ASCO/FDA Lung Cancer Endpoints Workshop April 15, 2003 [The following comments...
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf T o combat the one of the world's most devastating diseases, pharmaceutical and biotechnology researchers are testing 83 medicines for HIV/ AIDS and related conditions, intensifying their efforts and achieving steady progress in the development of vaccinesDaunoXome ® Gilead Sciences advanced AIDS- related Kaposi's sarcoma daunorubicin Foster...
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf page 10
Reference Listed Drug Labeling Approved in February 2002 - VIRACEPT letter label nelfinavir mesylate tablet 20-779 S-038 - VIRACEPT letter label nelfinavir mesylate oral powder 20-778 S-017 - ZOLADEX 3-month letter label goserelin acetate implant 20-578 S-013 - ZOLADEX 3.6 mg letter label goserelin acetate implant 19-726 S-034 Feb 6 MIRADON letter label anisindione tablet 10-909 S-013 - BUSPAR letter label buspirone HCl tablet 18-731 S-046...
author: USERNAME
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf P harmaceutical and biotechnology companies continue to research new and more effective ways to treat and prevent HIV/ AIDS, which affects an estimated 40 million people worldwide and has caused nearly half a million deaths in the United States aloneDaunoXome ® Gilead Sciences advanced AIDS- related Kaposi's sarcoma daunorubicin Foster City, CA...
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf page 11
02-Cattel (237-249) Tumori, 89: 237- 249, 2003 Aga Mac Dati PS Tumori 3/ 03 Cattel Sdaunorubicin, doxorubicin, liposomes, stealth liposomes
author: Dati
http://www.protivabio.com/_white_papers/gene_therapy_chapter.pdf Liposomal formulaa homogeneous small size with a mean diameter of I 100 tions of both daunorubicin and doxorubicin are currently nm (Figdaunorubicin, has been partially ameliorated VDaunorubicin (...
http://www.protivabio.com/_white_papers/gene_therapy_chapter.pdf page 10
BIO Editors &Reporters 03LIVE page 56
author: Elinor
C:\data\My Documents\NDAs\50704\ltrs\slr008ap.doc page 1
author: Dianne Spillman
