Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 49

DECLARATION re #44 MOTION to Dismiss for Lack of Subject Matter Jurisdiction and Failure to State a Claim by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit Exhibit 1, Part 1#2 Exhibit Exhibit 1, Part 2#3 Exhibit Exhibit 1, Part 3#4 Exhibit Exhibit 1, Part 4#5 Exhibit Exhibit 1, Part 5#6 Exhibit 2#7 Exhibit 3#8 Exhibit 4#9 Exhibit 5#10 Exhibit 6#11 Exhibit 7#12 Exhibit 8)(Huston, Julia)

Approval Times for Priority and Standard NMEs

Page 1 of 2

Case 1:05-cv-12237-WGY

Priority Calendar Year Number Approved 13 12 10 18 9 16 19 9 6.2 6.3 6.0 6.4 7.7 7.9 7.9 9.6 6.7 6.2 6.9 6.0 13.9 14.0 13.9 14.9 12 9 19 35 30 14 16 18 Number Approved Median F DA Review Time (months Median Total Approval Time (months)

Document 49-9

Standard Median F DA Review Time (months) 27.2 22.2 15.9 14.6 14.4 12.3 14.0 15.4 Median Total Approval Time (months) 27.2 23.7 17.8 15.1 15.0 13.4 16.3 19.9

1993 1994 1995 1996 1997 1998 1999 2000

Filed 04/11/2006 Page 1 of 2 EXHIBIT 4

http://www.fda.gov/cder/rdmt/NMEapps93-04.htm

3/7/2006

Approval Times for Priority and Standard NMEs

Page 2 of 2

2001 2002 2003 2004* 21 6.0 6.0 15 16.0 24.7 9 6.7 6.7 12 13.8 23.1 7 13.8 16.3 10 12.5 15.9

7

6.0

6.0

17

15.7

19.0

Case 1:05-cv-12237-WGY

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Document 49-9

Date created: March 22, 2005

Filed 04/11/2006 Page 2 of 2

http://www.fda.gov/cder/rdmt/NMEapps93-04.htm

3/7/2006