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VIOXX

NDA

ROFECOXIB | N021052 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Teva Pharmaceuticals USA FDA-2005-P-0150 · 5 docket documents Teva Pharmaceuticals USA filed this citizen petition on February 18, 2005, requesting that the FDA determine whether Vioxx Tablets, manufactured by Merck, should be considered withdrawn from sale for safety or efficacy reasons under 21 CFR 314.162. Teva sought this determination to enable approval o	505(q)	2010-07-23	Withdrawn	Teva Pharmaceuticals USA

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

27 trials from ClinicalTrials.gov, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)NCT00092300	Phase 3	Completed	Merck Sharp & Dohme LLC	450	2002-05
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC NCT00385606	Phase 2/3	Completed	National Cancer Institute, Naples	400	2003-01 → 2006-07
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)NCT00092313	Phase 3	Completed	Merck Sharp & Dohme LLC	271	2002-06 → 2002-09
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen NCT01762891	N/A	Completed	Hospital Universitario Pedro Ernesto	22	2003-03 → 2009-09
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)NCT00157872	Phase 4	Completed	Merck Sharp & Dohme LLC	150	2004-01-07 → 2004-09-19
A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee NCT00568295	Phase 3	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	403	1999-10 → 2000-10
Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer NCT00031863	Phase 3	Completed	Cancer Research Campaign Clinical Trials Centre	—	2001-02 → 2007-09
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)NCT00092339	Phase 3	Completed	Merck Sharp & Dohme LLC	125	2002-08-01 → 2002-09-15
Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction NCT00026819	Phase 2	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	150	2001-11 → 2003-11
Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)NCT00060476	Phase 3	Completed	Merck Sharp & Dohme LLC	15,000	2003-01-08 → 2004-12-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHASUN CHEMICALS AND DRUGS LTDInactiveROFECOXIB

DMF 166172003

AARTI DRUGS LTDInactiveROFECOXIB

DMF 298582015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
May 11, 2016	SUPPL -24	View Letter (PDF)
Sep 16, 2004	SUPPL -21	View Letter (PDF)
Aug 25, 2004	SUPPL -19	View Letter (PDF)
Jun 30, 2004	SUPPL -8	View Letter (PDF)
Jun 30, 2004	SUPPL -9	View Letter (PDF)
Dec 19, 2003	SUPPL -17	View Letter (PDF)
Aug 15, 2003	SUPPL -12	View Letter (PDF)
Jul 6, 2003	SUPPL -14	View Letter (PDF)
Jul 6, 2003	SUPPL -15	View Letter (PDF)
Jul 6, 2003	SUPPL -16	View Letter (PDF)
Apr 11, 2002	SUPPL -4	View Letter (PDF)
Apr 11, 2002	SUPPL -6	View Letter (PDF)
Apr 11, 2002	SUPPL -5	View Letter (PDF)
Apr 11, 2002	SUPPL -7	View Letter (PDF)
May 20, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 12.5MG/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: May 20, 1999

No patent or exclusivity listings for this strength.

#002 — 25MG/5ML

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: May 20, 1999