Recent examples of studies that have provided information to specific review decisions include: (1) interactions and metabolism studies of anti-cancer drugs such as paclitaxel, (2) anti-abuse drugs such as LAAM, (3) anti-HIV drugs such as the protease inhibitors, (4) anti-epileptic drugs, (5) cardiovascular drugs, and (6) anti-malarial drugs. In addition to the general technical expertise brought to bear on these problems, results from the program have been incorporated into final product labeling for some drugs, including paclitaxel and saquinavir. Labeling changes for other drugs are under discussion. Also, cutting- edge issues regarding cases of intermediate potency for cytochrome P450 pathways are under investigation.
EXPECTED DATE OF COMPLETION:10/01/2001
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Jerry Collins, 301-427-1065
PIC ID: 7103
PERFORMER: Food and Drug Administration, Rockville MD