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Details for Generic Name: rofecoxib

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Rofecoxib is the generic ingredient in one branded drug marketed by Merck and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for rofecoxib.

Summary for Generic Name: rofecoxib

Drug Master File Entries: see list1
Formulation / Manufacturing:see details

Clinical Trials for: rofecoxib

A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis of the Knee

CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
Status: Completed Condition: Antiphospholipid Antibody Syndrome

Study of Vioxx and Radiation Therapy for Brainstem Glioma
Status: Terminated Condition: Glioma; Brain Neoplasms

Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)
Status: Completed Condition: Prostate Cancer

GECO: Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced Non-Small Cell Lung Cancer
Status: Completed Condition: Advanced Non-Small Cell Lung Cancer

A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain
Status: Terminated Condition: Acute Pain

Safety of Lumiracoxib in Patients With Osteoarthritis
Status: Completed Condition: Osteoarthritis

Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Status: Completed Condition: Colorectal Cancer

Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction
Status: Completed Condition: Pain

Rofecoxib and Bupivacaine to Prevent Pain After Third Molar (Wisdom Tooth) Extraction
Status: Completed Condition: Pain; Tooth Extraction

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
SUSPENSION;ORAL021052-002May 20, 1999DISCNNo5,691,374*PED<disabled>Y<disabled>
TABLET;ORAL021042-002May 20, 1999DISCNNo5,691,374*PED<disabled>Y<disabled>
SUSPENSION;ORAL021052-002May 20, 1999DISCNNo6,063,811*PED<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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