http://www.biosis.org/ts/media/cdjournals/gazettenews/2000/CPG_News_0045.pdf NOVEMBER 10TH 2000 WEEK 45 DRUG PATENTING IN CONTEXT NEW THIS WEEK Good News for AstraZeneca as the EPO grants claims to its magnesium salt of the proton- pump inhibitor esomeprazole, the key active ingredient in Nexium.......
BioPortfolio Limited The Gastrointestinal Market 2003: New Blockbusters and Competitive Dynamics 1 Gastrointestinal Conditions 1.1 An Introduction to Gastrointestinal Conditions 1.2 Report Objectives 1.3 Worldwide Impact of Gastrointestinal Conditions 1.3.1 Demographic Prevalence Graph 1.1 Percentage of Hospitalizations Due to Gastrointestinal Causes Graph 1.2 Percentage of Diagnostic and Therapeutic...
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...
M:\Nexium\NDA 21-153_SLR-008\1-2004 NDA 21-153-SLR-008 approval lette\ r.doc NDA 21- 153/ S- 008 Page 3 93466XX 620514- XX NEXIUM ® (esomeprazole magnesium) DELAYED- RELEASE CAPSULES Rx only DESCRIPTION The active ingredient in NEXIUM (esomeprazole magnesium) Delayed- Release Capsules is bis( 5- methoxy- 2- [( S)-[( 4- methoxy- 3,5- dimethyl- 2- pyridinyl) methyl] sulfinyl]- 1H- benzimidazole- 1- yl) magnesium trihydrate, a...
author: Melissa Furness
M:\Nexium\NDA 21-153_SLR-008\1-2004 NDA 21-153-SLR-008 approval lette\ r.doc page 1
author: Melissa Furness
21-154 & 21-153 Nexium Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Nexium (Esomeprazole Magnesium) Delayed-Release Capsules Company:--AstraZeneca LP Application No.:--21-153 & 21-154 Approval Date:-2/20/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 6 - Part 2 - Part 7 - Part 3 - Part 8 - Part 4 - Part...
author: Paul Stauffer
NDA Approvals for Calendar Year 2001 NDA APPROVALS FOR CALENDAR YEAR 2001 Updated through December 31, 2001 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21-252 Canasa Mesalamine Axcan Scandipharm 5 P 05-Jan-01 21-208 Remeron SolTab Mirtazapine Organon 3 S 12-Jan-01 21-227 Cancidas Caspofungin Acetate Merck Research Labs 1 P 26-Jan-01 21-261 Monistat 3 Combination...
author: Brenda Harmon
FDA Drug Approvals List February 2001 - Drug Approvals for February 2001 Definitions and Notes Original New Drug Applications Original Application #: 021169 Approval Date: 28-FEB-01 Trade Name: REMINYL Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: JANSSEN RESEARCH FDN Active Ingredient(s): GALANTAMINE HYDROBROMIDE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate dementia...
C:\My Documents\N21153.February-2001.AP.letter&labeling.doc NDA 21- 153 NDA 21- 154 Page 4 NEXIUM (esomeprazole magnesium) DELAYED- RELEASE CAPSULES Rx only DESCRIPTION The active ingredient in NEXIUM (esomeprazole magnesium) Delayed- Release Capsules is bis( 5- methoxy- 2-[( S)-[( 4- methoxy- 3,5- dimethyl- 2- pyridinyl) methyl] sulfinyl]- 1H- benzimidazole- 1- yl) magnesium trihydrate, a compound that inhibits...
author: Maria Walsh
C:\My Documents\N21153.February-2001.AP.letter&labeling.doc page 1
author: Maria Walsh
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION 13 C-UREA MERETEK 20-586 10-Jul-00 10-May-01 SE2 004 N 10.0 Provides for a decrease in dose of 13 C-urea...
author: Darlene Norris
Prescription and OTC Drug Product List 2/2001 PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
Vertex Pharmaceuticals Press Release November 18, 2005 FDA Approves Updated Labeling for LEXIVA - Coadministration With Esomeprazole Does Not Affect Blood Levels of LEXIVA - Cambridge, MA and Research Triangle Park, NC, November 18, 2005– GlaxoSmithKline (NYSE: GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers Skip to content Home Media Investors Careers Products Licensing Research Responsibility About us Contact us - - Nexium (esomeprazole) Nexium contains the medicine esomeprazole.
NEXIUMA® OUTPERFORMS LANSOPRAZOLE IN FIRST HEAD-TO-HEAD CLINICAL TRIALS Skip to content Home Media Press releases - 2005 - 2004 - 2003 - 2002 - 2001 - 2000 - 1999 - 1998 Corporate reports Facts, products, pipeline Image library Events calendar Media contacts Investors Careers Products Licensing Research Responsibility About us Contact us Home - - Media - - Press releases - -2001 - - function managePressContacts() { window.navigate("ncm.aspx?node=press");...
Nexium (esomeprazole) - proton pump inhibitor to treat acid reflux and stomach ulcers Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - - Products - -Gastrointestinal - - Nexium (esomeprazole) Nexium contains the medicine esomeprazole.
Nexium (esomeprazole) - proton pump inhibitor to treat acid reflux and stomach ulcers Esomeprazole is a type of medicine called a proton pump inhibitor (PPI) that works by blocking a particular molecule in a type of cell in the stomach, so reducing the amount of stomach acid produced.
Database N N - 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.
M:\Nexium\NDA 21-153_SLR-008\1-2004 NDA 21-153-SLR-008 approval lette\ r.doc page 2
author: Melissa Furness
C:\My Documents\N21153.February-2001.AP.letter&labeling.doc page 15
author: Maria Walsh
C:\My Documents\N21153.February-2001.AP.letter&labeling.doc page 2
author: Maria Walsh
Microsoft Word - Word File for pdf.doc page 6
author: melanieg
27292REVIEWInsF-InsB ASTRAZENECA NOT JUST A PHARMACEUTICAL COMPANY ANNUAL REVIEW 2001 AstraZeneca Annual Review 2001 Key achievements 01 SALES OF $16.5 BILLION, UP 8%* OPERATING PROFIT OF $4.2 BILLION, UP 6%* EARNINGS PER SHARE OF $1.77, UP 11% SHARE BUY- BACK PROGRAMME EXTENDED BY AN ADDITIONAL $2 BILLION PROGRESS WITH RANGE OF PROMISING MEGABRANDS DRIVES TRANSFORMATION STRATEGY NEXIUM ACHIEVES FULL...
author: macuser
duplicates:http://www.astrazeneca.com/annualrep2001/pdf/third.pdf
Peptic Ulcer: Peptic Disorders: Merck Manual Home Edition Drugs Used to Treat Peptic Disorders Type Drug Selected Side Effects Comments Antacids - Aluminum hydroxide Calcium carbonate Magnesium hydroxide Sodium bicarbonate Nausea, headache, weakness, loss of appetite, constipation (aluminum hydroxide) or diarrhea (magnesium hydroxide) Used mainly to relieve symptoms, not as a cure Histamine-2 blockers - Cimetidine Famotidine...
Peptic Ulcer: Peptic Disorders: Merck Manual Home Edition Drugs Used to Treat Peptic Disorders Type Drug Selected Side Effects Comments Antacids - Aluminum hydroxide Calcium carbonate Magnesium hydroxide Sodium bicarbonate Nausea, headache, weakness, loss of appetite, constipation (aluminum hydroxide) or diarrhea (magnesium hydroxide) Used mainly to relieve symptoms, not as a cure Histamine-2 blockers - Cimetidine Famotidine...
