Drugs

Activities Report of the Generic Drug Program (FY 2015)

GDUFA YEAR/
Actions This Month
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Refuse to Receive (RTR)1211 15 30 27 13       
Withdrawals612 2 11 7 13       
Approvals4528 29 25 27 19       
Tentative Approvals107 5 5 13 6       
Complete Responses (CR)4376 96 104 108 94       
Drug Master File Completeness Assessment (DMF CA)12455 71 92 86 55       

GDUFA YEAR/
Submissions This Month
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Abbreviated New Drug Applications (ANDA)5027 43 27 29 57       
CBE Supplements473385434411 420 439       
PAS Supplements45225133 37 55       
GDUFA YEAR/
Amendments
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Originals (Pre FY15) Administrative119228 388 339 429 372       
Originals (Pre FY15) Solicited (CR, ECD/IR)8680 178 320 582 503       
Originals (Pre FY15) Unsolicited398229 108 118 84 130       
Originals (FY15) Administrative121 20 30 21 23       
Originals (FY15) Tier 100 0 0 0 1       

Originals (FY15) Tier 2

00 0 0 0 1       
Originals (FY15) Tier 3 00 0 0 0 0       
Originals (FY15) ECD/IR07 4 43 37 54       
PAS Supplements (Pre FY15) Administrative521 15 18 14 9       
PAS Supplements (Pre FY15) Solicited (CR, ECD/IR)4735 88 45 42 53       
PAS Supplements (Pre FY15) Unsolicited4321 11 11 10 9       
PAS Supplements (FY15) Administrative16 3 7 2 7       
PAS Supplements (FY15) Tier 100 0 0 0 1       
PAS Supplements (FY15) Tier 200 0 0 1 0       
PAS Supplements (FY15) Tier 300 0 0 0 0       
PAS Supplements (FY15) ECD/IR00 3 4 11 28       
CBE Amendments (all years together)61342972 71 101       
GDUFA YEAROct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Controls159128 141 166 104 137       
GDUFA Post CR Meeting Requests +8489 96 105 113 123       
Post CR Meeting Requests This month057 9 8 10       

 + = Revised to reflect more accurate counting by the GDRP.  For example RTRs revised to include both RTR due to failure to pay user fees and RTR due to technical reasons.              
 ++ = Starting FY15 ANDA Original Receipts are reported as raw receipts (versus filed receipts).              
 +++ = FY 15 Controls have been revised to count only those requests appropriate for a control.              
 ++++ = Cumulative and NOT specific to the month.   

DMF raw receipts have been eliminated since DMF Completeness Assessments present a more accurate indication of workload.    

Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes. 

 

 

Page Last Updated: 04/30/2015
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