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  1. Development & Approval Process (Drugs)

Pediatric Exclusivity Statistics

Pediatric Exclusivity Statistics

Printable Excel File (XLS - 39 KB)

As of April 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) 83
Updated
40
DPP (Division of Psychiatry Products) 65 
Updated
47
DOP1 (Division of Oncology Products 1) 34 21
DOP2 (Division of Oncology Products 2) 60 
Updated
33 
Updated
DHP (Division of Hematology Products) 99
Updated
39
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) 76
Updated
29
Updated
DMEP (Division of Metabolism and Endocrinology Products) 142
Updated
49
DAIP (Division of Anti-Infective Products) 33 11
DAVP (Division of Anti-Viral Products) 67
Updated
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) 64
Updated
34
DBRUP (Division of Bone, Reproductive and Urologic Products) 37 14
DTOP (Division of Transplant and Ophthalmology Products) 42 54
TOTAL 1057
Updated
553
Updated

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

Written Requests with PPSRs - 473

Updated

Written Requests without PPSRs 80  
Incomplete Responses - 530

Updated

PPSR Withdrawals - 32
Written Request Withdrawals - 10
Written Request Amendments - 653

Updated

TOTAL ACTIONS = 1778

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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