Drugs

Pediatric Exclusivity Statistics

as of January 31, 2015

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

DCRP (Division of Cardiovascular Renal Products)

   78  44

DNP (Division of Neurology Products)

   73 Updated  35

DPP (Division of Psychiatry Products)

   63  39

DOP1 (Division of Oncology Products 1)

   34  21

DOP2 (Division of Oncology Products 2)

   29 Updated  17

DHP (Division of Hematology Products)

   58 Updated  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 Updated  39

DGIEP (Division of Gastroentereology and Inborn Products)

   62  25

DMEP (Division of Metabolism and Endocrinology Products)

  116 Updated  44 Updated

DAIP (Division of Anti-Infective Products)

  20   5

DAVP (Division of Anti-Viral Products)

  58  46

DDDP (Division of Dermatology and Dental Products)

  54Updated  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)

  52    26

DBRUP (Division of Bone, Reproductive and Urologic Products)

  35 Updated  13

DTOP (Division of Transplant and Ophthalmology Products)

  45  54
TOTAL882 Updated 462 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 382 Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 417 Updated 
PPSR Withdrawals - 27
Written Request Withdrawals - 9
Written Request Amendments - 535 Updated 
TOTAL ACTIONS = 1450 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: 02/13/2015
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