A	B	C
1	Main
2		Brand Name	Avodart, Jalyn (US combination), Duodart (EU combination).
3		Generic Name	dutasteride (Jalyn/Duodart is combination dutasteride and tamsulosin).
4		Indication	BPH, Reducing risk of prostate cancer
5		Timeline	1/26/11 Received CRL for prostate cancer.
6			6/14/10 FDA approves Jalyn combination.
7			3/31/10 EMEA approval of Duodart.
8			5/29/10 Resubmitted prostate cancer sNDA.
9			10/1/09 Submitted prostate cancer sNDA.
10		IP	COM 5565467 expires 11/20/2015, COM 5998427 expires 9/17/2013.
11		Clinical Trials
12			Phase III COMBAT combination versus individual drugs
13
14
15
16			Phase III REDUCE n=8121
17			Reduced risk of all biopsy-detectable prostate cancer by 23%