Drugs

Pediatric Exclusivity Statistics

as of February 28, 2015

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

DCRP (Division of Cardiovascular Renal Products)

   79 Updated  44

DNP (Division of Neurology Products)

   74 Updated  35

DPP (Division of Psychiatry Products)

   63  39

DOP1 (Division of Oncology Products 1)

   35 Updated  21

DOP2 (Division of Oncology Products 2)

   30 Updated  17

DHP (Division of Hematology Products)

   58  25

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)

   61 Updated  25

DMEP (Division of Metabolism and Endocrinology Products)

  119 Updated  44

DAIP (Division of Anti-Infective Products)

  20   5

DAVP (Division of Anti-Viral Products)

  59 Updated  47 Updated

DDDP (Division of Dermatology and Dental Products)

  52Updated  17

DNCE (Division of Nonprescription Evaluation)

  11 Updated   5

DNRD (Division of  Nonprescription Regulation Development)

   0   0

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  54 Updated    26

DBRUP (Division of Bone, Reproductive and Urologic Products)

  36 Updated  13

DTOP (Division of Transplant and Ophthalmology Products)

  45  54
TOTAL892 Updated 463 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 383 Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 419 Updated 
PPSR Withdrawals - 27
Written Request Withdrawals - 9
Written Request Amendments - 537 Updated 
TOTAL ACTIONS = 1455 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- some PPSRs were transferred to other divisions which are organized by therapeutic area within the Pediatric Exclusivity database.

Page Last Updated: 03/10/2015
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