Celecoxib NDA 20-998 Medical Officer Review Submission Date: June 29, 1998 Received Date: June 30, 1998 Review Date: July.

 

Celecoxib NDA 20-998 Medical Officer Review Submission Date: June 29, 1998 Received Date: June 30, 1998 Review Date: July.

 

I. Background: Does the product have an acceptable margin of safety as based on prior prescription marketing experience Does the product have a low misuse.

 

1 Medical Officer Safety Review I. Background: Plan B was approved for use as an emergency contraceptive on July 28, 1999 and launched8-23 - 99. The product contains only a progestin,.

 

I. Background: Does the product have an acceptable margin of safety as based on prior prescription marketing experience Does the product have a low misuse.

 

Drug Name Medical Reviewer Medical Team Leader Martin H. Cohen, M. D. Isagani Chico, M. D. Grant Williams, M. D. Documents reviewed EDR Submissions.

 

Drug Name Medical Reviewer Medical Team Leader Martin H. Cohen, M. D. Isagani Chico, M. D. Grant Williams, M. D. Documents reviewed EDR Submissions.

 

CLINICAL REVIEW Table of Contents Executive Summary. 10 Clinical Review. 16 1. Introduction and Backgr ound. 16 1. 1 Proposed Indication, Drug Trade Name,.

 

Oncology Drugs Advisory Committee Meeting of December 18, 2002 NDA 20-498/s012 Applicant AstraZeneca Pharmaceuticals LP PO Box 8355 Wilmington, DE 19803-8355 Submission Type.

 

Oncology Drugs Advisory Committee Meeting of December 18, 2002 NDA 20-498/s012 Applicant AstraZeneca Pharmaceuticals LP PO Box 8355 Wilmington, DE 19803-8355 Submission Type.

 

Oncology Drugs Advisory Committee Meeting of December 18, 2002 NDA 20-498/s012 Applicant AstraZeneca Pharmaceuticals LP PO Box 8355 Wilmington, DE 19803-8355 Submission Type.

 

Medical Officer’s Primary Revi ew of Efficacy and Safety Oncology Drugs Advisory Committe e Meeting of December Applicant AstraZeneca Pharmaceuticals LP PO Box 8355.

 

Medical Officer’s Primary Revi ew of Efficacy and Safety Oncology Drugs Advisory Committe e Meeting of December Applicant AstraZeneca Pharmaceuticals LP PO Box 8355.

 

Medical Office ReviewNAI Hiffman Market Review 2012 Forecast Pictured Above: The new 14-story, 830,000-square foot Rush University Medical.

 

Medical Office ReviewNAI Hiffman Market Review 2013 Forecast Pictured Above: The entrance to the new Ann Robert H. Lurie Children’s Hospital of Chicago,.

 

Excerpts from primary review of NDA 21-042 - Osteoarthritis Submission date letter : November 23, 1998. Review date: December 1998 – May1999.

 

NDA 21-042/s007. VIOXX rofecoxib. Addendum To: Lawrence Goldkind, M. D. , Deputy Division Director, DAAODP Through: James Witter, M. D. , Ph. D. , Team Leader, DAAODP.

 

December 20, 1994 -- Merck opens Investigational New Drug IND 46,894 for osteoarthritis and acute pain in the Division of Analgesic and Ophthalmic Drug Products. This.

 

BEXTRA Valdecoxib, 10 and 20 mg Tablet REGULATORY HISTORY OF SIGNIFICANT EVENTS Submission Date Submission Type Details Approval Date 16 January 2001.

 

BEXTRA Valdecoxib, 10 and 20 mg Tablet REGULATORY HISTORY OF SIGNIFICANT EVENTS Submission Date Submission Type Details Approval Date 16 January 2001.

 

US IND 48,395 CELEBREX ® Celecoxib 100 mg, 200 mg, 400mg 1REGULATORY HISTORY OF SIGNIFICANT EVENTS 13 July 1995Original submission of IND 48,395N/A 09 February 1996End of Phase I meetingClinical.

 

Indication: Analgesia, Dysmenorrhea Osteoarthritis, and Rheumatoid Arthritis Reviewer: Kent Johnson, MD Date: November 7, 2001 NDA: 21,341 EXECUTIVE SUMMARY.

 

NDA 21-042/s007. VIOXX rofecoxib. Addendum To: Lawrence Goldkind, M. D. , Deputy Division Director, DAAODP Through: James Witter, M. D. , Ph. D. , Team Leader, DAAODP.

 

Celecoxib NDA 20-998 Medical Officer Review Submission Date: June 29, 1998 Received Date: June 30, 1998 Review Date: July.

 

Excerpts from primary review of NDA 21-042 - Osteoarthritis Submission date letter : November 23, 1998. Review date: December 1998 – May1999.

 

BRIEFING PACKAGE FOR NDA 21-389 ETORICOXIB I. Introduction: The following review summarizes the safety data for NDA 21-389 submitted by Merck, for the drug etoricoxib. It focuses.

 

1 Briefing package for Lumiracoxib 1/18/05 Preliminary review of GI Reviewer: Lourdes Villalba, MD, MO. Team Leader: James Witter, MD, Ph. D. 1. Background The primary outcome.

 

US IND 48,395 CELEBREX ® Celecoxib 100 mg, 200 mg, 400mg 1REGULATORY HISTORY OF SIGNIFICANT EVENTS 13 July 1995Original submission of IND 48,395N/A 09 February 1996End of Phase I meetingClinical.

 

Parecoxib Sodium NDA 21-294 Medical Officer Review Submission Date: September 11, 2000 Received Date: September 12, 2000 Review Date:.

 

DESCRIPTION VIOXX rofecoxib is described chemically as 4- 4- methylsulfonyl phenyl -3-phenyl-2 5H -furanone. It has the following chemical structure: Rofecoxib is a white to off-white to light.

 

BRIEFING PACKAGE FOR NDA 21-389 I. Introduction: The following review summarizes the safety data for NDA 21-389 submitted by Merck, for the drug etor icoxib. It focuses.

 

Memo to file 3/12/02 NDA 21-042/s007. VIOXX rofecoxib. Addendum To: Lawrence Goldkind, M. D. , Deputy Division Director, DAAODP Through: Jame s W itter,.

 

Graham, David J. , Memorandum dated September 30, 2004. Note: An error occurs when printing this document; Page 16 prints blank.

 

Hawkey C, Farkouh M, Gitton X, Eshrsam E, Huels J, Richardson P. Therapeutic Arthritis Research and Event Trial of lumiracoxib – study design and patient demographics.

 

DESCRIPTION TRADENAME established name is a member of the group of nonsteroidal anti inflammatory drugs NSAIDs. Each color description tablet/capsule contains.

 

Preliminary review of GI and CV data from TARGET Reviewer: Lourdes Villalba, MD, MO. Team Leader: James Witter, MD, Ph. D. 1. Background The TARGET Therapeutic COX189.

 

Celecoxib NDA 20-998/S-009 Medical Officer Review Submission Date: June 12, 2000 Received Date: June 14, 2000 Review Date: September.

 

VIOXX – NDA 21-042 / 21-052 M. L. Villalba,M. O. 1Vioxx Excerpts from primary review of NDA 21-042 - Osteoarthritis Submission date letter :November 23, 1998.

 

NDA 21-341 BEXTRA Valdecoxib, 10 and 20 mg Tablet REGULATORY HISTORY OF SIGNIFICANT EVENTS Submission DateSubmission Date 16 January 2001Original NDAOriginal New Drug Application16.

 

Preliminary review of GI and CV data from TARGET Reviewer: Lourdes Villalba, MD, MO. Team Leader: James Witter, MD, Ph. D. 1. Background The TARGET Therapeutic COX189.

 

NDA 21-042/s007 VIOXX 1 FOOD AND DRUG ADMINISTRATION DIVISION OF ANALGE SIC AND OPHTHALMIC DRUG PRODUCTS -- HFD-550 Medical Officer Review VIOXX Rofecoxib.

 

Sequence of Events with VIOXX, since opening ofIND1. December 20, 1994 -- Merck opens Investiga tional New Drug IND 46,894 for osteoarthritis.

 

Excerpts from primary review of NDA 21-042 - Osteoarthritis Submission date letter : November 23, 1998. Review date: December 1998 – May1999.