Drugs

Pediatric Exclusivity Statistics

as of July 31, 2016

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

DCRP (Division of Cardiovascular Renal Products)

   83Updated  48

DNP (Division of Neurology Products)

   74  36Updated

DPP (Division of Psychiatry Products)

   57  41

DOP1 (Division of Oncology Products 1)

   32Updated  21

DOP2 (Division of Oncology Products 2)

   39Updated  20

DHP (Division of Hematology Products)

   64Updated  28

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)

   79  39

DGIEP (Division of Gastroentereology and Inborn Products)

   67  28

DMEP (Division of Metabolism and Endocrinology Products)

  129Updated  44

DAIP (Division of Anti-Infective Products)

  22   7

DAVP (Division of Anti-Viral Products)

  59  47

DDDP (Division of Dermatology and Dental Products)

  55Updated  21Updated

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  55Updated  29

DBRUP (Division of Bone, Reproductive and Urologic Products)

  35  14

DTOP (Division of Transplant and Ophthalmology Products)

  42  55
TOTAL917  490Updated

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


Written Requests with PPSRs - 410 Updated 
Written Requests without PPSRs - 80  
Incomplete Responses - 456  
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 572Updated  
TOTAL ACTIONS = 1556Updated

*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: 08/09/2016
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