Drugs

Pediatric Exclusivity Statistics

as of June 30, 2015

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

DCRP (Division of Cardiovascular Renal Products)

   81Updated  47

DNP (Division of Neurology Products)

   76 Updated  35

DPP (Division of Psychiatry Products)

   56Updated  39

DOP1 (Division of Oncology Products 1)

   33  21

DOP2 (Division of Oncology Products 2)

   31Updated  17

DHP (Division of Hematology Products)

   56  26

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)

   64Updated  26Updated

DMEP (Division of Metabolism and Endocrinology Products)

  118  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  20Updated

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)

  36  13

DTOP (Division of Transplant and Ophthalmology Products)

  44  54
TOTAL886 Updated 471 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 391 Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 428 Updated 
PPSR Withdrawals - 27
Written Request Withdrawals - 9
Written Request Amendments - 549 Updated 
TOTAL ACTIONS = 1484 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: 07/16/2015
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