Drugs
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Pediatric Exclusivity Statistics
as of May 31, 2013
| Review Division | Proposed Pediatric Study Requests (PPSRs) Received | Written Requests Issued * |
|---|---|---|
| DCRP (Division of Cardiovascular Renal Products) | 70 | 44 |
| DNP (Division of Neurology Products | 66  | 31 |
| DPP (Division of Psychiatry Products) | 54 | 36 |
| DOP1 (Division of Oncology Products 1) | 31 | 19 |
| DOP2 (Division of Oncology Products 2) | 26 | 15 |
| DHP (Division of Hematology Products) | 48 | 20 |
| DHOTP (Division of Hematology Oncology Toxicology Products) | 0 | 0 |
| DMIP (Division of Medical Imaging Products) | 18 | 7 |
| DAAP (Division of Analgesia, Anesthesia, and Addiction Products) | 78 | 39 |
| DGIEP (Division of Gastroentereology and Inborn Products) | 55 | 23 |
| DMEP (Division of Metabolism and Endocrinology Products) | 106 | 39 |
| DAIP (Division of Anti-Infective Products) | 19 | 5 |
| DAVP (Division of Anti-Viral Products) | 53 | 42 |
| DDDP (Division of Dermatology and Dental Products) | 42 | 17 |
| DNCE (Division of Nonprescription Evaluation) | 10 | 5 |
| DNRD (Division of Nonprescription Regulation Development) | 0 | 0 |
| DPARP (Division of Pulmonary, Allergy and Rheumatology Products) | 43 | 23 |
| DRUP (Division of Reproductive and Urologic Products) | 35 | 13 |
| DTOP (Division of Transplant and Ophthalmology Products) | 43 | 52 |
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Numbers reflect the number of drugs (i.e., active moiety) per division.
TOTAL Actions
354 Written Requests with PPSRs
76 Written Requests without PPSRs
379 Incomplete Responses
26 PPSR Withdrawals
9 Written Request Withdrawals
514 Written Request Amendments
TOTAL = 1358
*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/WRs were transferred to other divisions which are organized by therapeutic area within the Pediatric Exclusivity database.
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