Drugs

Pediatric Exclusivity Statistics

as of May 31, 2015

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

DCRP (Division of Cardiovascular Renal Products)

   79  47Updated

DNP (Division of Neurology Products)

   75 Updated  35

DPP (Division of Psychiatry Products)

   60  39

DOP1 (Division of Oncology Products 1)

   33Updated  21

DOP2 (Division of Oncology Products 2)

   30Updated  17

DHP (Division of Hematology Products)

   56Updated  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)

   61  25

DMEP (Division of Metabolism and Endocrinology Products)

  118 Updated  44

DAIP (Division of Anti-Infective Products)

  19   5

DAVP (Division of Anti-Viral Products)

  60  47

DDDP (Division of Dermatology and Dental Products)

  54Updated  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 Updated  26

DBRUP (Division of Bone, Reproductive and Urologic Products)

  36Updated  13

DTOP (Division of Transplant and Ophthalmology Products)

  44Updated  54
TOTAL884 Updated 470 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 390 Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 426 Updated 
PPSR Withdrawals - 27
Written Request Withdrawals - 9
Written Request Amendments - 548 Updated 
TOTAL ACTIONS = 1480 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: 06/12/2015
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