Microsoft Word - 20050928.doc Forest Laboratories' growing line of products includes: Lexapro( R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda( R)( memantine HCl), an N- methyl- D- aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe Alzheimer...
author: MGieson
Microsoft Word - 20050928.doc page 3
author: MGieson
http://www.biosis.org/ts/media/cdjournals/gazettenews/2003/CPG_News_0350.pdf week 0350 12 Dec 2003 AstraZeneca has several interesting applications published this week.
Gazette Highlights News 2003 - Thomson Scientific Thomson.com - - - - - Advanced Search - - - EN : JP : CN : KR -- - - Thomson Scientific : Gazette Weekly Highlights News : Gazette Highlights News 2003 - Gazette Highlights News 2003 Click on a week to view more Week 51: This issue of Current Patents Gazette is the final one for 2003...Olmesartan medoxomil also now has a UK SPC, due to come into force in February 2012...
Press Releases | News Releases News Releases Glucowatch® Biographer Reported to Improve Diabetes Control in Children Study published in PEDIATRICS is first ever to demonstrate that monitoring glucose with the Biographer could affect HbA1c levels.
Press Releases | News Releases News Releases GlucoWatch® Biographer May Potentially Prevent Numerous Incidences of Severe Diabetic Complications Additional Biographer Data Presented at the American Diabetes Association's Annual Meeting Demonstrates Reading Correlation with Mealtime Blood Glucose Measurements and A1c Parsippany, NJ and Redwood City, CA — June 16, 2003 — Data presented today at the...
Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc
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,...
Reference Listed Drug Labeling Approved in October 2002 Oct 1 THYROLAR-3 letter label liotrix tablets 16-807 SLR 025 Oct 1 VUMON letter label teniposide for injection 20-119 SLR 004 Oct 2 PAXIL letter label paroxetine HCl tablets 20-031 SE8 035 Oct 2 WELLBUTRIN letter label bupropion HCl tablets 18-644 SLR 024 Oct 2 WELLBUTRIN SR letter label bupropion HCl extended-release tablets 20-358 SLR 024 Oct 2 ZAGAM letter label sparfooxacin...
author: USERNAME
CDER 2002 Report to the Nation; Drug Review Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document 1 Drug Review Index Mission Highlights New Drug Review List of priority new drugs List of new molecular entities List of orphan new drugs New Drug Review Statistics Priority new drug statistics...
author: OLIVERN
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
NMEs Approved in CY 2002 NMEs Approved in Calendar Year 2002 - NDA Number Generic Name Trade Name Dosage Form Applicant *Classification Approval Date 21-232 Nitisinone Orfadin Capsule Swedish Orphan -- 1PV 01-18-2002 21-286 Olmesartan Medoxomil Benicar Tablet Sankyo- 1S 04-25-2002 21-344 Fulvestrant Faslodex Injection AstraZeneca 1S 04-25-2002 21-272 Treprostinil Sodium Remodulin Injection...
author: Susan Daugherty
Prescription and OTC Drug Product List 4/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
Microsoft Word - N21532AP.doc page 2
author: FROMME
Microsoft Word - N21532AP.doc page 1
author: FROMME
\\CDSDCRDP1\SBENTON\PM Folder\NDA ltrs\21286ap.doc page 1
author: Edward Fromm
E:\PM Folder\NDA ltrs\21286S002ap.doc page 1
author: Edward Fromm
http://www.phrma.org/newmedicines/resources/2003-01-30.102.pdf Holmer President and CEO PhRMA 2 N E W D R U G A P P R O V A L S I N 2002 0 500 1000 1500 2000 2500 3000 3500 4000 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 NUMBER OF CLINICAL TRIALS OF NEW MEDICINES 3 N E W D R U G A P P R O V A L S I N 2002 New Drug Approvals in 2002 NDA FDA Review Foreign Product ompany Indication/ Use Received Approved Time...
http://www.phrma.org/newmedicines/resources/2003-01-30.102.pdf page 12
http://www.phrma.org/newmedicines/resources/2003-01-30.102.pdf page 3
DURindex02.qxd NOV: 5 Cardiovascular risk assessment: COX- 2, APR: 6 Caspofungin drug evaluation, DEC: 1 Darbepoetin alfa (Aranesp) formulary evaluation, JUN: 1 Drug- induced nightmare, JUN: 6 Drug interactions with birth control pills, MAY: 6 Drug interactions with thyroid drugs, MAY: 4 Exogenous lung surfactants in the management of neonatal respiratory distress syndrome, MAR: 1 Fluoroquinolone...
author: BeckJ
DURindex02.qxd page 1
author: BeckJ
Benicar Consumer Information Benicar ® Brand Name: Benicar ® Active Ingredient: - olmesartan medoxomil - Strength(s): 5 mg, 20 mg, and 40 mg Dosage Form(s): - Tablets- Company Name: -- Sankyo Pharma IncBenicar used forBenicar is used to treat high blood pressure in adultsBenicar Benicar if you are...
E:\PM Folder\NDA ltrs\21286s001ap.doc page 1
author: Edward Fromm
FY 2002 User Fee NME Approvals FY 2002 USER FEE NME APPROVALS as of September 30, 2002 NDA # Trade Name (Generic Name) -Dosage Form Applicant Approval Date- Class Indication 21-187 NuvaRing (etonogestrel/ethinyl estradiol) Vaginal Ring Organon 3-Oct-01 1S NuvaRing is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception
author: Brenda Harmon
