http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 IMATINIB MESYLATE NOVARTIS < td WIDTH="75"> 21-335 SE5 003 28-Jun-02 20-May-03 Y 10.7 Provides for the use of Gleevec (imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapyMESYLATE GENESOFT PHARMS 21-158 SE1 001 4...
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 July 2002 PEDIATRIC Dosage Form: INJECTABLE Applicant: NEOSAN PHARMACEUTICALS Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 018154 Labeling Supplement #: 023 To Original New Drug...
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
Prescription and OTC Drug Product List 6/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
February Drug Approvals Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
FDA Drug Approvals List- January 1998 Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status...
FDA Drug Approvals List November 2000 Active Ingredient(s): VINORELBINE TARTRATE OTC/RX Status: RX Application #: 018936 Labeling Supplement #: 063 To Original New Drug Application Approval Date: 28-NOV-00 Trade Name: PROZAC Dosage Form: CAPSULE Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO Active Ingredient(s): FLUOXETINE HYDROCHLORIDE OTC/RX Status: RX Application #: 018936 Labeling Supplement #: 062 To...
http://www.fda.gov/cder/ogd/rld/20628s14.PDF Jolson, MD, MPH Director Division of Antiviral Drug Products Center for Drug Evaluation and Research INVIRASE ® (saquinavir mesylate) CAPSULES DESCRIPTION: INVIRASE brand of saquinavir mesylate is an inhibitor of the human immunodeficiency virus (HIV) proteaseINVIRASE ® (saquinavir mesylate) capsules and FORTOVASE ® (...
http://www.fda.gov/cder/ogd/rld/20628s14.PDF page 1
DDPA December 1995 Drug and Device Approvals-December 1995 December 1995 - FDA Drug and Device Product Approvals ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-628 INVIRASE ROCHE SAQUINAVIR MESYLATE 06-DEC-95 (CAPSULE) NUTLEY, NJ EQ 200MG BASE (1 P, AA*, E**, H***) 07110 (ANTIVIRAL) [TREATMENT OF ADVANCED HIV INFECTION IN SELECTED PATIENTS IN COMBINATION WITH NUCLEOSIDE...
DDPA June 1996 74-515 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.25% BASE 62525 (BETA ADRENERGIC BLOCKER) 74-516 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.5% BASE 62525 (BETA ADRENERGIC BLOCKER) 16-096 MINTEZOL MSD THIABENDAZOLE 03-JUN-96 (TABLET, CHEWABLE) WEST POINT, PA 500MG 19486 (LABELING REVISION -- INDICATIONS AND USAGE;...
Drug Approvals September 1996 CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
bjla211.tmp CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: Application Number: 20- 628/ S007 Trade Name: INVIRASE CAPSULES Generic Name: SAQUINAVIR MESYLATE CAPSULES Sponsor: HOFFMAN- LA ROCHE INC Approval Date: 02/ 27/ 97 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION: 20- 628/ S007 CONTENTS Included Pending Not Not Completion Prepared Required Approval...
author: fda
1997 New Drug Application (NDA) 020070/S004 S006 10/10/1997 3/20/1998 Cordarone (amiodarone HCI) I.V., 50 mg/ml in 3 ml vial Wyeth-Ayerst Laboratories 20377 - S2 12/10/1997 8/11/2003 Corlopam/Fenoldopam Mesylate Approval Letter [169 KB] Medical Review Part 1 [4.2 MB] Part 2 [5 MB] Part 3 [4.8 MB] Chemistry Review & EA/FONSI [1.9 MB] Pharmacology Review Part 1 [3.3 MB] Part 2 [2.3 MB] Statistical Review &...
IFPMA News: News Releases: 'Cambodia Treatment Access Project' to provide HIV Care, Research and Training .LeftCalloutPos { position:absolute; left:402px; top:0px; }.RightCalloutPos { position:absolute; left:586px; top:0px; } - News Releases - - - Contact Us - - - News & Publications News Releases In the Media Speeches Publications Marketing Code Events Press Contacts 'Cambodia Treatment Access Project' to provide HIV Care, Research and Training Hoffmann-La Roche (Roche) - NUTLEY, N.J.,...
Protease inhibitors (PIs) for HIV - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Protease inhibitors (PIs) for HIV - [Medication] - Quest Diagnostics Patient Health Library Protease inhibitors (PIs) for HIV - [Medication] - Quest Diagnostics Patient Health Library Immune system, Agenerase, amprenavir, antiretroviral agents,...
LabHorizons Newsletter vol4 no2 2nd qtr 2004.qxd 007740 Acetaminophen (Tylenol ® ), Serum 700005 Acetaminophen, Serum 717330 Amikacin, Serum, Peak/ Trough 007204 Amikacin Peak, Serum 007203 Amikacin Random, Serum 007205 Amikacin Trough, Serum 706705 Amiodarone (Cordarone ® ), Serum 007476 Amitriptyline (Elavil ® ), Serum 017487 Amitriptyline and Nortriptyline 017178 Amobarbital, Serum 007914 Anticonvulsant Profile...
author: ellerb
LabHorizons Newsletter vol4 no2 2nd qtr 2004.qxd page 3
author: ellerb
HIV EMERGENCIES Indinavir, nelfinavir, ritonavir, saquinavir n n Combinations: n n One NNRTI + two NRTIs - Efavirenz + (zidovudine AZT or tenofovir or stavudine d4T) One or two PIs + two NRTIs - lopinavir/ritonavir Kaletra +(zidovudine or stavudine) + lamivudine 3TC Three NRTIs – abacavir ABC + (zidovudine AZT or stavudine D4T) Goals of Therapy n Results of therapy are evaluated through...
author: Caroline Kowal
G:\DAVDP\CSO\HOLLOMAN\NDAS\NDA 20628 INVIRASE\SE2-020 EFFICACY SUP\ PLEMENT\ACTION PACKAGE\AP LTR with ATTACHED LABELING 12-24-2003.doc Lamb: Please refer to your supplemental new drug application dated February 20, 2003 and received February 24, 2003, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for INVIRASE ® (saquinavir mesylate) 200 mg Capsules
author: Marsha Holloman
G:\DAVDP\CSO\HOLLOMAN\NDAS\NDA 20628 INVIRASE\SE2-020 EFFICACY SUP\ PLEMENT\ACTION PACKAGE\AP LTR with ATTACHED LABELING 12-24-2003.doc page 1
author: Marsha Holloman
Roche Patents - - - - - - - - - - The development of a new drug has been calculated to cost on average more than 800 million US dollars and take between 10-12 years
Roche Selected Products Therapeutic Area Product Brand Name / Main Indication Indication Anesthesia and sedation Dormicum/Versed midazolam Cancer Furtulon doxifluridine Cancer of the colon Herceptin trastuzumab Breast cancer Kytril granisetron hydrochloride Cancer Mabthera/Rituxan rituximab Non-Hodgkin's lymphoma Roferon-A interferon alfa-2a Cancer Xeloda capecitabine Breast cancer Cardiovascular diseases...
