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  1. Development & Approval Process (Drugs)

Pediatric Exclusivity Statistics

Pediatric Exclusivity Statistics

Printable Excel File (XLS - 38 KB)

As of July 1, 2019

Review Division
 
Proposed Pediatric Study Requests (PPSRs) Received * Written Requests Issued
DCRP (Division of Cardiovascular Renal Products) 89 50
DNP (Division of Neurology Products) 85 40
DPP (Division of Psychiatry Products) 65  47
DOP1 (Division of Oncology Products 1) 35 21
DOP2 (Division of Oncology Products 2) 62
Updated
35
Updated
DHP (Division of Hematology Products) 103
Updated
40
Updated
40DMIP (Division of Medical Imaging Products ) 14 7
DAAAP (Division of Analgesia, Anesthesia and Addiction Products) 80 40
DGIEP (Division of Gastroentereology and Inborn Products) 77 29
DMEP (Division of Metabolism and Endocrinology Products) 144 51
Updated
DAIP (Division of Anti-Infective Products) 33 11
DAVP (Division of Anti-Viral Products) 67 54
DDDP (Division of Dermatology and Dental Products) 63 26
DNDP (Division of Nonprescription Drug Products) 10 5
DPARP (Division of Pulmonary, Allergy and Rheumatology Products) 65 34
DBRUP (Division of Bone, Reproductive and Urologic Products) 37 14
DTOP (Division of Transplant and Ophthalmology Products) 42 54
TOTAL 1070
Updated
559
Updated

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

Written Requests with PPSRs - 479

Updated

Written Requests without PPSRs 80  
Incomplete Responses - 535

Updated

PPSR Withdrawals - 32
Written Request Withdrawals - 10
Written Request Amendments - 659

Updated

TOTAL ACTIONS = 1795

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/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.

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