Pediatric Exclusivity Statistics

as of July 31, 2015

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

DCRP (Division of Cardiovascular Renal Products)

   82Updated  47

DNP (Division of Neurology Products)

   74 Updated  35

DPP (Division of Psychiatry Products)

   56  39

DOP1 (Division of Oncology Products 1)

   33  21

DOP2 (Division of Oncology Products 2)

   31  17

DHP (Division of Hematology Products)

   57Updated  27Updated

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   16   7

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   80  39

DGIEP (Division of Gastroentereology and Inborn Products)

   63Updated  26

DMEP (Division of Metabolism and Endocrinology Products)

  119Updated  44

DAIP (Division of Anti-Infective Products)

  20   5

DAVP (Division of Anti-Viral Products)

  60  47

DDDP (Division of Dermatology and Dental Products)

  54  20

DNCE (Division of Nonprescription Evaluation)

  11   5

DNRD (Division of  Nonprescription Regulation Development)

   0   0

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  52  26

DBRUP (Division of Bone, Reproductive and Urologic Products)

  34Updated  13

DTOP (Division of Transplant and Ophthalmology Products)

  44  54
TOTAL884 Updated 472 Updated

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

Written Requests with PPSRs - 392 Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 429 Updated 
PPSR Withdrawals - 29 Updated
Written Request Withdrawals - 9
Written Request Amendments - 553 Updated 
TOTAL ACTIONS = 1492 Updated

*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: 08/12/2015
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