Jevtana Clinical Development

Date	Action
IND Chronology (#56,999)
4/14/1999	IND activated
6/28/2006	End-0f-Phase II meeting
9/11/2006	Special Protocol Assessment request granted for pivotal study EFC6193
7/30/2008	“Dear Investigator” letter from sponsor directs clinical trial investigators to follow ASCO guidelines concerning use of G-CSF to reduce neutropenia risk
11/9/2009	Fast Track designation
12/18/2009	First sections of application submitted under rolling submission allowed fast track products
2/23/2010	Pre-NDA meeting
NDA Chronology (#20-1023)
3/31/2010	NDA submission completed
4/22/2010	Division of Drug Oncology Products requests consult with Study Endpoints and Labeling Development Team regarding the patient-reported outcome of pain intensity in Phase III
5/11/2010	Trade Name Jevtana found acceptable by Division of Medication Error Prevention and Analysis
6/17/2010	Approval
6/18/2010	Expedited review action goal
9/30/2010	PDUFA goal date (priority review)