Drugs

Pediatric Exclusivity Statistics

Printable Excel File (XLS - 32 KB)

As of August 20, 2018

Review Division
 
Proposed Pediatric Study Requests (PPSRs) Received* Written Requests Issued
DCRP (Division of Cardiovascular Renal Products)8750
DNP (Division of Neurology Products)81 Updated38
DPP (Division of Psychiatry Products)6346
DOP1 (Division of Oncology Products 1)3321
DOP2 (Division of Oncology Products 2)56 Updated30 Updated
DHP (Division of Hematology Products)92 Updated37 Updated
DMIP (Division of Medical Imaging Products )147
DAAAP (Division of Analgesia, Anesthesia and Addiction Products)8040
DGIEP (Division of Gastroentereology and Inborn Products)74 Updated28
DMEP (Division of Metabolism and Endocrinology Products)138 Updated47
DAIP (Division of Anti-Infective Products)3311
DAVP (Division of Anti-Viral Products)6754
DDDP (Division of Dermatology and Dental Products)5726
DNDP (Division of Nonprescription Drug Products)105
DPARP (Division of Pulmonary, Allergy and Rheumatology Products)6234 Updated
DBRUP (Division of Bone, Reproductive and Urologic Products)3714
DTOP (Division of Transplant and Ophthalmology Products)4154
TOTAL1025541

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

Written Requests with PPSRs - 461 Updated
Written Requests without PPSRs 80  
Incomplete Responses - 501 Updated
PPSR Withdrawals - 32
Written Request Withdrawals - 10
Written Request Amendments - 636 Updated
TOTAL ACTIONS = 1720 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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Page Last Updated: 08/20/2018
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