Symlin "approvable" letter
Executive Summary
Amylin will conduct additional trials of antidiabetic Symlin (pramlintide) prior to approval. The trials could focus on dose titration. Amylin is discussing clinical protocol for further studies with FDA after the agency deemed the product "approvable" Oct. 12
You may also be interested in...
Amylin Exenatide NDA Filing Expected Mid-2004; Symlin Launch in Q1
Amylin is eyeing a mid-2004 filing date for its exenatide NDA
Amylin Exenatide NDA Filing Expected Mid-2004; Symlin Launch in Q1
Amylin is eyeing a mid-2004 filing date for its exenatide NDA
Amylin To Resubmit Symlin In June; Ex-Guidant Exec Graham Named CEO
Amylin's resubmission plans for Symlin will give the diabetes agent a chance for approval before the end of 2003