Pediatric Exclusivity Statistics

Printable Excel file:_2017 Aug_WRsPPSR_stats.xls

as of July 31, 2017

Review DivisionProposed Pediatric Study Requests (PPSRs) ReceivedWritten Requests Issued *

DCRP (Division of Cardiovascular Renal Products)

   83 Updated  49

DNP (Division of Neurology Products)

   75  36

DPP (Division of Psychiatry Products)

   60 Updated  44 Updated

DOP1 (Division of Oncology Products 1)

   33 Updated  21

DOP2 (Division of Oncology Products 2)

   49 Updated   26 

DHP (Division of Hematology Products)

   73 Updated  32

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   14 Updated   7

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   80  40

DGIEP (Division of Gastroentereology and Inborn Products)

   67  28

DMEP (Division of Metabolism and Endocrinology Products)

  132 Updated  46

DAIP (Division of Anti-Infective Products)

  27   8

DAVP (Division of Anti-Viral Products)

  66 Updated  53 

DDDP (Division of Dermatology and Dental Products)

  55 Updated  23 

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  56Updated  29

DBRUP (Division of Bone, Reproductive and Urologic Products)

  34  14

DTOP (Division of Transplant and Ophthalmology Products)

  41  54
TOTAL955Updated  515 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.

Written Requests with PPSRs - 433 Updated 
Written Requests without PPSRs 80  
Incomplete Responses - 473 Updated  
PPSR Withdrawals - 32
Written Request Withdrawals - 10 Updated
Written Request Amendments - 609Updated  
TOTAL ACTIONS = 1639Updated

*This column will never equal the number of proposals submitted, because a Written Request may be issued without a proposal, and a proposal may result in an action that is incomplete instead of a Written Request.

*New/Transfers/Miscodes- some PPSRs were transferred to other divisions or deleted due to miscodes.  The PPSRs are organized by therapeutic area within the Pediatric Exclusivity database.

Page Last Updated: 09/21/2017
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