Medtronic Corporate Technologies and New Ventures

Generic drug repurposing in oncology faces challenges due to lack of financial incentives and focus on de novo drug development. Nonprofits and non-manufacturers are advancing this field, but regulatory approval for new indications is difficult. A proposed 'labeling-only 505(b)(2) NDA' could streamline approval for non-manufacturers, increasing utilization of low-cost generics and improving patient outcomes.