MainThe straightforward number of applications approved is a high level measure of the overall performance of OGD. However, it does not reflect all review work accomplished, such as the time invested reviewing applications that are not approvable. <br>These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. </b> Number0

FY 2010 Total: 426

Oct 200925Nov 200943Dec 200931Jan 201018Feb 201026Mar 201028Apr 201046May 201044Jun 201064Jul 201042Aug 201030Sep 2010290

FY 2011 Total: 458

Oct 201039Nov 201028Dec 201039Jan 201127Feb 201135Mar 201145Apr 201130May 201152Jun 201156Jul 201150Aug 201127Sep 201130

FY 2012 YTD: 109

Oct 201143Nov 201127Dec 201139Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainThe straightforward number of applications tentatively approved is a high level measure of the overall performance of OGD. However, it does not reflect all review work accomplished, such as the time invested reviewing applications that are not approvable.Number0

FY 2010 Total: 142

Oct 20098Nov 20099Dec 200915Jan 201019Feb 20104Mar 20109Apr 201017May 201019Jun 201012Jul 20108Aug 201011Sep 2010110

FY 2011 Total: 139

Oct 201013Nov 20109Dec 201012Jan 201113Feb 201110Mar 201112Apr 201117May 20116Jun 20114Jul 20119Aug 201120Sep 201114

FY 2012 YTD: 24

Oct 20117Nov 20118Dec 20119Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainNumber0

FY 2010 Total: 1,514

Oct 2009151Nov 200999Dec 2009128Jan 2010134Feb 2010102Mar 2010160Apr 2010118May 2010101Jun 2010144Jul 2010131Aug 2010108Sep 20101370

FY 2011 Total: 1,679

Oct 2010139Nov 2010130Dec 2010144Jan 2011157Feb 2011140Mar 2011149Apr 2011133May 2011102Jun 2011180Jul 2011116Aug 2011167Sep 2011122

FY 2012 YTD: 491

Oct 2011126Nov 2011191Dec 2011174Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainThe pending review queue is affected by the number of new applications submitted, the number of amended applications needing additional review cycles, and the number of applications that cannot be approved due to patents, exclusivities, complex issues or the need to address matters raised in citizen petitions. Overall review capacity affects the capability to address the queue.Numbercolumn0

FY 2010 Total: 2,236

Oct 20091,747Nov 20091,786Dec 20091,912Jan 20101,940Feb 20101,983Mar 20102,068Apr 20102,102May 20102,101Jun 20102,136Jul 20102,158Aug 20102,198Sep 20102,2250

FY 2011 Total: 2,500

Oct 20102,247Nov 20102,280Dec 20102,361Jan 20112,356Feb 20112,390Mar 20112,448Apr 20112,479May 20112,485Jun 20112,478Jul 20112,485Aug 20112,485Sep 20112,500

FY 2012 YTD: 2,693

Oct 20112,497Nov 20112,558Dec 20112,693Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012SubNumber of Pending Applications (cumulative as of end of month)Numbercolumn0

FY 2010 Total: 871

Oct 2009716Nov 2009735Dec 2009768Jan 2010786Feb 2010806Mar 2010827Apr 2010844May 2010863Jun 2010850Jul 2010859Aug 2010878Sep 20108720

FY 2011 Total: 659

Oct 2010856Nov 2010840Dec 2010820Jan 2011808Feb 2011794Mar 2011776Apr 2011749May 2011746Jun 2011722Jul 2011695Aug 2011677Sep 2011659

FY 2012 YTD: 596

Oct 2011638Nov 2011629Dec 2011596Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainNumber0

FY 2010 Total: 813

Oct 200958Nov 200957Dec 2009129Jan 201050Feb 201057Mar 201075Apr 201059May 201070Jun 201078Jul 201064Aug 201044Sep 2010730

FY 2011 Total: 893

Oct 201078Nov 201085Dec 2010122Jan 201170Feb 201155Mar 201198Apr 201175May 201169Jun 201169Jul 201156Aug 201155Sep 201161

FY 2012 YTD: 338

Oct 201158Nov 201170Dec 2011210Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012MainNumber0

Oct 2010N/ANov 2010N/ADec 2010N/AJan 2011N/AFeb 2011N/AMar 2011N/AApr 2011N/AMay 2011N/AJun 2011N/AJul 2011N/AAug 2011N/ASep 201111

FY 2012 YTD: 30

Oct 201114Nov 201112Dec 20114Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboardhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/default.htmANDA (Generic) Drug Approvals