"The US Food and Drug Administration's (FDA's) Arthritis Drugs Advisory Committee gave its backing to CT-P13, a drug that would be the first biosimilar monoclonal antibody approved in the United States.
The committee voted 21â€“3 that CT"...
(Generic versions may still be available.)
No overdoses of VIOXX (rofecoxib) were reported during clinical trials. Administration of single doses of VIOXX (rofecoxib) 1000 mg to 6 healthy volunteers and multiple doses of 250 mg/day for 14 days to 75 healthy volunteers did not result in serious toxicity.
In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
VIOXX (rofecoxib) is contraindicated in patients with known hypersensitivity to rofecoxib or any other component of VIOXX (rofecoxib) .
VIOXX (rofecoxib) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma).
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/28/2004
Additional Vioxx Information
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