Drugs

Pediatric Exclusivity Statistics

as of December 30, 2016

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

DCRP (Division of Cardiovascular Renal Products)

   83  48

DNP (Division of Neurology Products)

   74 Updated  36

DPP (Division of Psychiatry Products)

   60  41

DOP1 (Division of Oncology Products 1)

   32  21

DOP2 (Division of Oncology Products 2)

   45 Updated  23 Updated

DHP (Division of Hematology Products)

   68Updated  29

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   15   7

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   80  40

DGIEP (Division of Gastroentereology and Inborn Products)

   68  28

DMEP (Division of Metabolism and Endocrinology Products)

  130  46

DAIP (Division of Anti-Infective Products)

  22   7

DAVP (Division of Anti-Viral Products)

  66  50

DDDP (Division of Dermatology and Dental Products)

  54  21

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  55  29

DBRUP (Division of Bone, Reproductive and Urologic Products)

  34 Updated  14

DTOP (Division of Transplant and Ophthalmology Products)

  42  55
TOTAL939Updated  500Updated

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


Written Requests with PPSRs - 420 Updated 
Written Requests without PPSRs 80  
Incomplete Responses - 464Updated  
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 585Updated  
TOTAL ACTIONS = 1589Updated

*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: 01/09/2017
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