Drugs

Pediatric Exclusivity Statistics

as of August 31, 2016

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

DCRP (Division of Cardiovascular Renal Products)

   84Updated  48

DNP (Division of Neurology Products)

   74  36

DPP (Division of Psychiatry Products)

   57  41

DOP1 (Division of Oncology Products 1)

   32  21

DOP2 (Division of Oncology Products 2)

   41Updated  20

DHP (Division of Hematology Products)

   66Updated  29Updated

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   15   7

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   79  39

DGIEP (Division of Gastroentereology and Inborn Products)

   67  28

DMEP (Division of Metabolism and Endocrinology Products)

  129  45Updated

DAIP (Division of Anti-Infective Products)

  22   7

DAVP (Division of Anti-Viral Products)

  62Updated  47

DDDP (Division of Dermatology and Dental Products)

  54Updated  21

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  55  29

DBRUP (Division of Bone, Reproductive and Urologic Products)

  35  14

DTOP (Division of Transplant and Ophthalmology Products)

  42  55
TOTAL924Updated  492Updated

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


Written Requests with PPSRs - 412 Updated 
Written Requests without PPSRs - 80  
Incomplete Responses - 455Updated  
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 577Updated  
TOTAL ACTIONS = 1564Updated

*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: 09/07/2016
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