DIVISION OF ANALGESIC AND OPHTHALMIC DRUG PRODUCTS -- HFD-550 Medical Officer Review Re: Complete response to Approvable letter for 21-042/S 007 and 21-052/S 004 Submission.

 

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

 

DIVISION OF ANALGESIC AND OPHTHALMIC DRUG PRODUCTS -- HFD-550 Medical Officer Review VIOXX Rofecoxib NDA 21-042 capsules and NDA 21-052 oral solution.

 

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

 

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

 

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.

 

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.

 

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

 

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.

 

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.

 

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.

 

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

 

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.

 

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

 

VIOXX® rofecoxib tablets and oral suspension DESCRIPTION VIOXX rofecoxib is described chemical ly as 4- 4- methylsulfonyl phenyl -3- phenyl-2 5H -furanone. It has the follo wing.

 

Proposed NSAID Package Insert Labe ling Template Revised 12/19/96 TRADENAME Established name which should always include.

 

Page 1 FOOD AND DRUG ADMINISTRATION DIVISION OF ANALGESIC AND OPHTHALMIC DRUG PRODUCTS -- HFD-550 Medical Officer Review NDA 21-042 and NDA 21-052 Rofecoxib.

 

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

 

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 No. 20-998 CELEBREX ® Celecoxib 100 mg , 200 mg, 400 mg Celebrex Capsules Celecoxib NDA 20-998 Medical Officer Review Submission Date: June 29, 1998 Received Date:.

 

DIVISION OF ANALGESIC AND OPHTHALMIC DRUG PRODUCTS -- HFD-550 Medical Officer Review Re: Complete response to Approvable letter for 21-042/S 007 and 21-052/S 004 Submission.

 

12/18/04 In terim Review VIOXX rofecoxib Review of NDA 21042 /s030 Update of Cardiovascular thrombotic events inAlzh eimer’s studies 078 and 091 Review.

 

division of analgesic, and ophthalmologic drug products, HFD-550, Tel: 301 827-2040 DATE: January 19, 2005 TO: Members and Consultants Arthritis and Drug Safety.

 

Background package for February, 2005 AC meeting. IND 46,894 – Vioxx Sponsor: Merck Reviewer: Lourdes Villalba, M. D. , MO, HFD-550 1. Background: Merck withdrew.

 

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

 

REGULATORY HISTORY OF SIGNIFICANT EVENTS Date Event Details 13 July 1995 Original submission of IND 48,395 N/A 09 February 1996 End of Phase I meeting.