Drugs

Pediatric Exclusivity Statistics

as of November 30, 2014

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

DCRP (Division of Cardiovascular Renal Products)

   79  44

DNP (Division of Neurology Products)

   73  35

DPP (Division of Psychiatry Products)

   63 Updated  39

DOP1 (Division of Oncology Products 1)

   34  24 Updated

DOP2 (Division of Oncology Products 2)

   29  17

DHP (Division of Hematology Products)

   59 Updated  23

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   17   8

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   78  38

DGIEP (Division of Gastroentereology and Inborn Products)

   62Updated  25

DMEP (Division of Metabolism and Endocrinology Products)

  115 Updated  43

DAIP (Division of Anti-Infective Products)

  21   5

DAVP (Division of Anti-Viral Products)

  57  45

DDDP (Division of Dermatology and Dental Products)

  48 Updated  17

DNCE (Division of Nonprescription Evaluation)

  13   5

DNRD (Division of  Nonprescription Regulation Development)

   0   0

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  53 Updated   26

DBRUP (Division of Bone, Reproductive and Urologic Products)

  35  13

DTOP (Division of Transplant and Ophthalmology Products)

  45  54
TOTAL881 Updated 459 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 379 Updated  
Written Requests without PPSRs - 80  
Incomplete Responses - 415 Updated 
PPSR Withdrawals - 27
Written Request Withdrawals - 9
Written Request Amendments - 533 Updated 
TOTAL ACTIONS = 1443 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: 12/11/2014
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