• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Pediatric Exclusivity Statistics

as of March 31, 2014

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

DCRP (Division of Cardiovascular Renal Products)

   77 Updated  44

DNP (Division of Neurology Products)

   76 Updated  33 Updated

DPP (Division of Psychiatry Products)

   58  36

DOP1 (Division of Oncology Products 1)

   31  19

DOP2 (Division of Oncology Products 2)

   29  15

DHP (Division of Hematology Products)

   52 Updated  20

DHOTP (Division of Hematology Oncology Toxicology Products)

    0   0

DMIP (Division of Medical Imaging Products )

   19   8

DAAAP (Division of Analgesia, Anesthesia and Addiction Products)

   77  39

DGIEP (Division of Gastroentereology and Inborn Products)

   59 Updated  24

DMEP (Division of Metabolism and Endocrinology Products)

  115 Updated  42 Updated

DAIP (Division of Anti-Infective Products)

  21   5

DAVP (Division of Anti-Viral Products)

  57 Updated  44 Updated

DDDP (Division of Dermatology and Dental Products)

  43 Updated  17

DNCE (Division of Nonprescription Evaluation)

  14 Updated   5

DNRD (Division of  Nonprescription Regulation Development)

   0   0

DPARP (Division of Pulmonary, Allergy and Rheumatology Products)

  50 Updated  25

DBRUP (Division of Bone, Reproductive and Urologic Products)

  38  13

DTOP (Division of Transplant and Ophthalmology Products)

  46  54
TOTAL862 Updated 443 Updated

Numbers reflect the number of drugs (i.e., active moiety) per division.
Written Requests with PPSRs - 365 Updated 
Written Requests without PPSRs - 78
Incomplete Responses - 405 Updated
PPSR Withdrawals - 27
Written Request Withdrawals - 9
Written Request Amendments - 526 Updated
TOTAL ACTIONS = 1410 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.