Drugs

Pediatric Exclusivity Statistics

as of October  30, 2016

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

DCRP (Division of Cardiovascular Renal Products)

   83Updated  48

DNP (Division of Neurology Products)

   77 Updated  36

DPP (Division of Psychiatry Products)

   58  41

DOP1 (Division of Oncology Products 1)

   32  21

DOP2 (Division of Oncology Products 2)

   42  20

DHP (Division of Hematology Products)

   66Updated  29

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 Updated  40 Updated

DGIEP (Division of Gastroentereology and Inborn Products)

   68 Updated  28

DMEP (Division of Metabolism and Endocrinology Products)

  129  45

DAIP (Division of Anti-Infective Products)

  22   7

DAVP (Division of Anti-Viral Products)

  66Updated  50Updated

DDDP (Division of Dermatology and Dental Products)

  55  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
TOTAL933Updated  496Updated

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


Written Requests with PPSRs - 416 Updated 
Written Requests without PPSRs - 80  
Incomplete Responses - 459Updated  
PPSR Withdrawals - 31
Written Request Withdrawals - 9
Written Request Amendments - 581Updated  
TOTAL ACTIONS = 1575Updated

*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: 11/09/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English