Oncology Drugs Advisory Committee Meetings FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Oncology Drugs Advisory Committee Meetings List of Tentative Meeting Dates for All CDER Advisory Committees List of Committee Members Committee Charter CDER Contacts Current Year Meeting Information 2004 FDA Advisory Committee Calendar -Meeting information includes center, date, time and...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 1/21/99 1/26/99 Prograf (tacrolimus) capsules Fujisawa USA DDMAC 1/4/99 1/11/99 Remeron (mitrazapine) tablets Organon DDMAC 1/5/99 1/14/99 Risperdal (risperidone) tablets and oral solution Janssen Research DDMAC 1/5/99 1/14/99 Trivora, Zovia, Necon, Levora, Nor-QD Tablets Watson Laboratories DDMAC 1/26/99 2/12/99 February Arava (leflunomide) tablets Hoechst Marion Roussel DDMAC...
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
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Cyberbotanica: Camptothecin, Irinotecan Hydrochloride, and Topotecan Pharmacology of Camptothecin, Irinotecan and Topotecan [ Chemical Comparison Table | Camptotheca Page ] Camptothecin is a quinoline-based alkaloid found in the barks of the Chinese camptotheca tree and the Asian nothapodytes treeirinotecan HCl was approved as a treatment for metastatic cancer of the colon or rectum; the drug is...
FDA Drug Approvals List April 2000 - Drug Approvals for April 2000 Definitions and Notes Original New Drug Applications Original Application #: 021025 Approval Date: 21-APR-00 Trade Name: EXELON Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): RIVASTIGMINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate...
FDA Drug Approvals List Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
FDA Drug Approvals List- March 1998 PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRA USA INC Active Ingredient(s): ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E OTC/RX Status: RX Application #: 050672 Labeling Supplement #: 012 To Original New...
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 Also, under GRANULES FOR ORAL SUSPENSION in the DOSAGE AND ADMINISTRATION section, the age range for children in the dosing tables was expanded to -age 5 months through 12 years.- SOTALOL HYDROCHLORIDE BERLEX LABS 21-151 22-Jun-98 22-Feb-00 N 000 N 20.1 Provides for the new indication of prolongation of time to recurrence of symptomatic AFIB/AFL in patients with symptomatic...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
http://www.cancercare.on.ca/formulary/pdfdrugs/irinot.pdf Irinotecan CCO Formulary Revised Aug 2000 A DRUG NAME: IRINOTECAN SYNONYM( S): CPT- 11, Irinotecan hydrochloride trihydrate COMMON TRADE NAME( S): Camptosar R (Pharmacia- Upjohn) B MECHANISM OF ACTION AND PHARMACOKINETICS Irinotecan is a semi- synthetic derivative of camptothecin. Camptothecin ...
http://www.cancercare.on.ca/formulary/pdfdrugs/irinot.pdf page 6 Irinotecan CCO Formulary Revised Aug 2000 Diuretics Increase potential risk of dehydration, during periods of active diarrhea and vomiting Additive Monitor or avoid I RECOMMENDED CLINICAL MONITORING Recommended Clinical Monitoring Suggested Clinical Monitoring ° Routine toxicity rating ...
DDPA June 1996 Drug and Device Approvals-June 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-597 XALATAN PHARMACIA AND UPJOHN LATANOPROST 05-JUN-96 (SOLUTION/DROPS) COLUMBUS, OH 0.005% (1 P) 43216 (PROSTAGLANDIN ANALOGUE) [REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN-ANGLE GLAUCOMA AND OCULAR HYPERTENSION WHO ARE INTOLERANT OF OTHER INTRAOCULAR PRESSURE...
Mace L. Rothenberg, MD Home - About Antigenics - Leadership > Mace L.
http://corpcomm.amgen.com/abgenix/releases/2005-04-26a.html Phase 3 Clinical Trial Initiated to Evaluate the Use of Panitumumab Therapy For First- Line Treatment of Metastatic Colorectal Cancer Study Evaluates Panitumumab Administered With Bevacizumab and Chemotherapy THOUSAND OAKS, Calif.
author: pmannle
http://corpcomm.amgen.com/abgenix/releases/2005-04-26a.html page 1
author: pmannle
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Millennium | Media | Press Releases | 2002 | 2002-04-08 2003 2002 Millennium Researchers Announce Preclinical Findings of its Proteasome Inhibitor MLN341 Against Several Solid Tumor Types – Investigational compounds unique mechanism of action may also help overcome resistance to chemotherapy – Cambridge, Mass., April 8, 2002 - Millennium Pharmaceuticals, Inc.
Millennium | Media | Press Releases | 2002 | 2002-05-21 (Nasdaq: MLNM) announced that its investigational drug, MLN341 (formerly known as LDP-341 and PS-341), was well tolerated and showed early signs of anti-tumor activity when combined with standard chemotherapies Gemzar® (gemcitabine) and Camptosar ® (irinotecan hydrochloride injection) Injection in certain patients with pancreatic, lung and colorectal cancers.
Millennium | Media | Press Releases | 2002 | 2002-07-16 2003 2002 Millennium Reports Second Quarter 2002 Financial Results – Strong INTEGRILIN® (eptifibatide) Injection Sales; Significant Clinical Progress in Oncology Franchise – Cambridge, MA, July 16, 2002 - Millennium Pharmaceuticals, Inc.
Millennium | Media | Press Releases | 2002 | 2002-12-30 2003 2002 Millennium Initiates Phase II Clinical Trial with VELCADE™ (bortezomib) for Injection in Patients with Colorectal Cancer – First phase II Company-sponsored trial in solid tumors – Cambridge, Mass., (December 30, 2002) - Millennium Pharmaceuticals, Inc.
THE MERCK MANUAL, Sec. 3, Ch. 34, Tumors Of The Gastrointestinal Tract This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 3.
Hybridon, Inc. - Drug Development - Clinical Programs - Antisense - GEM®231 home Home | News | Events | Contact | Site Map - › About Hybridon Company Profile Our Vision Letter from the Chairman and the CEO Management Team Board of Directors › Technology IMO™ Technology Toll-like Receptors Agonists of TLR9 IMOxine® Amplivax™ Cancer Programs Infectious Disease Programs Asthma/Allergy Programs Combination with Vaccines and Antigens...
