Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -OptiMark (Gadoversetamide) Injection Company:- Tyco/Mallinckrodt Health Care Application No.:- 020937/S003, 020975/S003 & 20976/S003 Approval Date:-1/31/2003 Approval Letter(s) - - Printed Labeling - - Medical Review(s) - - Pharmacology Review(s) - - Administrative Document(s) -...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
20937_OptiMark.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search OptiMark (Gadoversetamide) Injection Company:- Mallinckrodt, Inc
author: Paul Stauffer
Report to the Nation: Drug Review Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate Ketotifen fumarate Levonorgestrel Nedocromil sodium Nitric oxide Orlistat Oseltamivir phosphate Pemirolast potassium Pioglitazone hydrochloride...
author: OLIVERN
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
C:\Data\My Documents\optimark\SE803apn209371292003.doc January 2003 OptiMARK ® 0.5mmol/ mL (Gadoversetamide Injection) PRESCRIBING INFORMATION Mallinckrodt IncGadoversetamide is a paramagnetic agent that develops a magnetic moment when placed in a magnetic fieldGadoversetamide does not undergo protein binding in vitroGadoversetamide (0.1 mmol/ kg) is eliminated...
author: James Moore
C:\Data\My Documents\optimark\SE803apn209371292003.doc page 2
author: James Moore
C:\Data\My Documents\optimark\SE803apn209371292003.doc page 1
author: James Moore
FDA Drug Approvals List December 1999 Original Application #: 020976 Approval Date: 08-DEC-99 Trade Name: OPTIMARK Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: MALLINCKRODT INC Active Ingredient(s): GADOVERSETAMIDE OTC/RX Status: RX Indication(s): For the use of optimark with magnetic resonance imaging (MRI) in patients with an abnormal blood brain barrier or abnormal...
CDER 1999 Report to the Nation 1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane (Aromasin) ...
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
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
Posters -- International Drug Development Group the Standard 21-Day Culture Method In Vitro Metabolism of Apomorphine by Human, Dog, and Rat Hepatocytes Plasma Protein Binding and Whole Blood Distribution of Apomorphine in Plasma and Blood from Human, Dog, Rat, and Mouse Transport Across Caco-2 Cell Monolayers of a Mixture of Beta-Adrenergic Receptor Antagonists ADME/PK Posters 14C Apomorphine: Enterohepatic Recirculation in Rats...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 *Supplement Type Description for SE1 - SE7 N (Chemical Type 6) SE1 SE2 SE3 SE4 SE5 SE6 SE7 NDA Type 6 - New Indication New or modified indication New dosage regimen New route of administration Comparative efficacy claim Patient population altered Change the marketing status from prescription to over the counter use Complete the traditional approval of a product originally approved...
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION DOCKET NO
http://www.abclabs.com/dd/idd_posters/BIO/MALLINCKRODTPL.PDF Analyte Analyte: : Gadoversetamide Gadoversetamide (MP- 1177) (MP- 1177) Internal Standard (LC- MS/ MS): Internal Standard (LC- MS/ MS): MP- 2077 MP- 2077 Matrix: Matrix: Human Plasma Human Plasma Assay Type: Assay Type: LC- MS/ MS LC- MS/ MS Sample Volume: Sample Volume: 1 1 mL mL Sample Preparation: Sample Preparation: Ultrafiltration Ultrafiltration (30,000 MWCO) (30...
http://www.abclabs.com/dd/idd_posters/BIO/MALLINCKRODTUR.PDF Analyte: Analyte: Gadoversetamide Gadoversetamide (MP- 1177) (MP- 1177) Internal Standard (LC- MS/ MS): Internal Standard (LC- MS/ MS): MP- 2077 MP- 2077 Matrix: Matrix: Human urine Human urine Assay Type: Assay Type: LC- MS/ MS LC- MS/ MS Sample Volume: Sample Volume: 1 1 mL mL Sample Preparation: Sample Preparation: Centrifugation (4000 X Centrifugation (4000 X g g) )...
