Drugs

Pediatric Exclusivity Statistics

Printable Excel file: APR_2017_WRsPPSR_stats.xls
 

as of April 30, 2017

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

DCRP (Division of Cardiovascular Renal Products)

   83  48

DNP (Division of Neurology Products)

   75  36

DPP (Division of Psychiatry Products)

   62 Updated  42

DOP1 (Division of Oncology Products 1)

   32  21

DOP2 (Division of Oncology Products 2)

   46 Updated  25 Updated

DHP (Division of Hematology Products)

   67  31Updated

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)

   80  40

DGIEP (Division of Gastroentereology and Inborn Products)

   67  28

DMEP (Division of Metabolism and Endocrinology Products)

  128  46

DAIP (Division of Anti-Infective Products)

  25 Updated   8Updated

DAVP (Division of Anti-Viral Products)

  65  52

DDDP (Division of Dermatology and Dental Products)

  54  22 Updated

DNDP (Division of Nonprescription Drug Products)

  10   5

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  54  29

DBRUP (Division of Bone, Reproductive and Urologic Products)

  34 Updated  14

DTOP (Division of Transplant and Ophthalmology Products)

  41 Updated  54 Updated
TOTAL938Updated  508 Updated

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


Written Requests with PPSRs - 428 Updated 
Written Requests without PPSRs 80  
Incomplete Responses - 468  Updated
PPSR Withdrawals - 32
Written Request Withdrawals - 9
Written Request Amendments - 596Updated  
TOTAL ACTIONS = 1613Updated

*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: 05/10/2017
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