Drugs
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Pediatric Exclusivity Statistics
as of August 31, 2012
| Review Division | Proposed Pediatric Study Requests (PPSRs) Received | Written Requests Issued * |
|---|---|---|
| DCRP (Division of Cardiovascular Renal Products) | 70  | 43 |
| DNP (Division of Neurology Products | 63 | 28 |
| DPP (Division of Psychiatry Products) | 53 | 35 |
| DOP1 (Division of Oncology Products 1) | 32 | 19 |
| DOP2 (Division of Oncology Products 2) | 20 | 16 |
| DHP (Division of Hematology Products) | 44 | 18 |
| 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) | 74 | 39 |
| DGIEP (Division of Gastroentereology and Inborn Products) | 47 | 23 |
| DMEP (Division of Metabolism and Endocrinology Products) | 94 | 37 |
| DAIP (Division of Anti-Infective Products) | 19 | 5 |
| DAVP (Division of Anti-Viral Products) | 49 | 42 |
| DDDP (Division of Dermatology and Dental Products) | 40 | 19 |
| DNCE (Division of Nonprescription Evaluation) | 8 | 5 |
| DNRD (Division of Nonprescription Regulation Development) | 0 | 0 |
| DPARP (Division of Pulmonary, Allergy and Rheumatology Products) | 40 | 22 |
| DRUP (Division of Reproductive and Urologic Products) | 33 | 12 |
| DTOP (Division of Transplant and Ophthalmology Products) | 43 | 49 |
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Numbers reflect the number of drugs (i.e., active moiety) per division.
TOTAL Actions
340 Written Requests with PPSRs
79 Written Requests without PPSRs
348 Incomplete Responses
26 PPSR Withdrawals
9 Written Request Withdrawals
496 Written Request Amendments
TOTAL = 1298
*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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