Bristol does "not agree with FDA's interpretation of the study results" for uracil/tegafur combination oncologic agent, Worldwide Medicines Group President Richard Lane says. Bristol received a "non-approvable" letter from FDA for UFT March 23, after it resubmitted the NDA (1"The Pink Sheet" April 2, In Brief). Bristol is "still reviewing our options"
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Oral colorectal cancer therapy receives "not approvable" letter from FDA March 23. The NDA for uracil/tegafur for the treatment of advanced colorectal cancer was resubmitted April 20, 2000 after being withdrawn March 17, 2000. FDA's Oncologic Drugs Advisory Committee recommended UFT for approval in September 1999 following analysis of the contribution of uracil. A 1,500-patient cooperative study for the adjuvant treatment of colorectal cancer is expected to complete in 2002
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials