Bristol-Myers Squibb UFT
FDA's Oncologic Drugs Advisory Committee will review Bristol's NDA for UFT capsules (tegafur/uracil) in combination with leucovorin calcium tablets for the first-line treatment of metastatic colorectal cancer on Sept. 16. Bristol's NDA for Orzel (UFT packaged with leucovorin calcium tablets) for the same indication will not be reviewed by the committee (1"The Pink Sheet" Aug. 9, In Brief). The two NDAs contain identical clinical data and were submitted simultaneously. Leucovorin is marketed by several manufacturers
You may also be interested in...
Bristol-Myers Squibb's submission of two separate NDAs for the combination use of UFT and leucovorin appears to be a new filing and approval strategy for the development of bundled multi-ingredient products.
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