Active Ingredient History
Valdecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, is classified as a nonsteroidal anti-inflammatory drug (NSAID). Valdecoxib was manufactured and marketed under the brand name Bextra. Bextra was indicated for relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis. For the treatment of primary dysmenorrhea. But in 2005 FDA requested that Pfizer withdraw Bextra from the American market, because the Agency had concluded that the overall risk versus benefit profile of Bextra was unfavorable. That conclusion was based on the potential increased risk for serious cardiovascular (CV) adverse events, an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra had not been shown to offer any unique advantages over the other available NSAIDs. NCATS
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Arthritis, Rheumatoid (approved 2001)
Osteoarthritis (approved 2001)
Acute Pain (Phase 4)
Anterior Cruciate Ligament Injuries (Phase 4)
Arthritis, Rheumatoid (Phase 4)
Cholangiopancreatography, Endoscopic Retrograde (Phase 2/Phase 3)
Cholecystectomy, Laparoscopic (Phase 3)
Dysmenorrhea (Phase 4)
Hallux Valgus (Phase 3)
Hyperalgesia (Phase 4)
Knee (Phase 3)
Low Back Pain (Phase 4)
Neurosurgery (Phase 4)
Osteoarthritis (Phase 3)
Osteoarthritis, Knee (Phase 2)
Pain (Phase 4)
Pain, Postoperative (Phase 4)
Pancreatitis (Phase 2/Phase 3)
Pharyngitis (Phase 3)
Sprains and Strains (Phase 4)
| Trial | Phase | Start Date | Organizations | Indications |
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