Drugs

Pediatric Exclusivity Statistics

as of June 30, 2016

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

DCRP (Division of Cardiovascular Renal Products)

   84Updated  48

DNP (Division of Neurology Products)

   74Updated  35

DPP (Division of Psychiatry Products)

   57Updated  41

DOP1 (Division of Oncology Products 1)

   31  21

DOP2 (Division of Oncology Products 2)

   40  20

DHP (Division of Hematology Products)

   63  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)

   67Updated  28

DMEP (Division of Metabolism and Endocrinology Products)

  126Updated  44

DAIP (Division of Anti-Infective Products)

  22   7

DAVP (Division of Anti-Viral Products)

  59  47

DDDP (Division of Dermatology and Dental Products)

  57Updated  20

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  56  29

DBRUP (Division of Bone, Reproductive and Urologic Products)

  35  14

DTOP (Division of Transplant and Ophthalmology Products)

  42  55
TOTAL917Updated  488Updated

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


Written Requests with PPSRs - 408  
Written Requests without PPSRs - 80  
Incomplete Responses - 456Updated  
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 570Updated  
TOTAL ACTIONS = 1554Updated

*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: 07/15/2016
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