Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date
FDA has not completed routine investigator site and CRO vendor inspections
OSAKA, Japan, Jan. 19 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, receive...
Clinical Trials of New Drug Febuxostat Show Promise in Gout Treatment
A new drug called febuxostat
has been found to reduce plasma levels of uric acid more effectively in Gout than the currently used drug allopurinol. If the results of the clinical trial are successful//, then it would mean the end of a 40 year search for successful treatment of Gout.
Gout is cha...
Studies examine treatment for gout and the condition's protective effects
...tion, but previous clinical trials have shown that febuxostat
is effective at lowering urate levels and that its...as conducted to compare the safety and efficacy of febuxostat
with allopurinal and a placebo in patients with hi...andomized to receive one of three dosage levels of febuxostat
once daily; allopurinol; or a placebo. The allopur...