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. 2013 Jan 31;76(3):396–411. doi: 10.1111/bcp.12085

Table 3.

FDA approval times

Submission date Approval date Interval in days
Axitinib 14 April 2011 27 January 2012 288
Bosutinib 17 November 2011 04 September 2012 292
Crizotinib* 30 March 2011 26 August 2011 149
Dasatinib* 28 December 2005 28 June 2006 182
Erlotinib* 30 July 2004 18 November 2004 111
Gefitinib* 05 August 2002 05 May 2003 273
Imatinib* 27 February 2001 10 May 2001 72
Lapatinib* 13 September 2006 13 March 2007 181
Nilotinib 29 September 2006 29 October 2007 396
Pazopanib 19 December 2008 19 October 2009 304
Regorafenib* 27 April 2012 27 September 2012 153
Ruxolitinib* 03 June 2011 16 November 2011 166
Sorafenib* 08 July 2005 20 December 2005 166
Sunitinib* 11 August 2005 26 January 2006 168
Vandetanib* 07 July 2010 06 April 2011 273
Vemurafenib* 28 April 2011 17 August 2011 111
Mean (n = 16) 205.3
Range 72–396
Mean for Priority review drugs (n = 12) 167.1
Mean for Standard review drugs (n = 4) 320.0
*

Designated for Priority review.