Drugs

Pediatric Exclusivity Statistics

as of March 31, 2016

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

DCRP (Division of Cardiovascular Renal Products)

   85  47

DNP (Division of Neurology Products)

   75  35

DPP (Division of Psychiatry Products)

   58  40

DOP1 (Division of Oncology Products 1)

   33  21

DOP2 (Division of Oncology Products 2)

   40Updated  20 Updated

DHP (Division of Hematology Products)

   61  28Updated

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  28Updated

DMEP (Division of Metabolism and Endocrinology Products)

  123Updated  44

DAIP (Division of Anti-Infective Products)

  22Updated   7

DAVP (Division of Anti-Viral Products)

  58  47

DDDP (Division of Dermatology and Dental Products)

  53  20

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  56  29Updated

DBRUP (Division of Bone, Reproductive and Urologic Products)

  35  14Updated

DTOP (Division of Transplant and Ophthalmology Products)

  42Updated  55Updated
TOTAL912Updated  486Updated

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


Written Requests with PPSRs - 406Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 445Updated  
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 567Updated  
TOTAL ACTIONS = 1538Updated

*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: 04/11/2016
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