ABSTRACT
For NDA - Metabolite studies as appropriate. - Excipient/impurity qualification studies as appropriate - 3-mo mouse dose range-finding study to support carcinogenicity
study (for chronic indicationb) - Rat and mouse carcinogenicity (for chronic indicationb) - Juvenile rat studies to support pediatric indication (if applicable) - Additional studies to address special issues (e.g., immunotoxicology)
discontinuous/intermittent treatment for a cumulative total of 6 mo or more.
