SYMLIN™ Regulatory Status
Approvable letter received from FDA in October 2001
Dose-titration study enrollment completed in August 2002
- patients enrolled in 7-month study
- Designed to provide enhanced knowledge of complementary actions of insulin/SYMLIN and better prescribing information
NDA amendment submission planned for 1H 2003
- FDA category 2 amendment (PDUFA review time ? 6 months)