-
Drugs
-
Pediatric Exclusivity Statistics
as of October 31, 2009
| Review Division | Proposed Pediatric Study Requests (PPSRs) Received | Written Requests Issued * |
|---|---|---|
| DCRP (Division of Cardiovascular Renal Drug Products) | 52 | 37 |
| DNP (Division of Neurology Products | 69 | 45 |
| DPP (Division of Psychiatry Products) | 17 | 10 |
| DDOP (Division of Drug Oncology Products) | 42 | 45 |
| DMIHP (Division of Medical Imaging and Hematology Products) | 16 | 7 |
| DAARP (Division of Analgesics, Anesthetics, and Rheumatology Products) | 59 | 36 |
| DGP (Division of Gastroentereology Products) | 48 | 21 |
| DMEP (Division of Metabolism and Endocrinology Products) | 104 | 42 |
| DAIOP (Division of Anti-Infective and Ophthalmology Products) | 29 | 35 |
| DAVP (Division of Anti-Viral Products) | 33 | 37 |
| DDDP (Divisioin of Dermatology and Dental Drug Products) | 38 | 17 |
| DNCE (Division of Nonprescription Evaluation) | 8 | 5 |
| DPAP (Division of Pulmonary and Allergy Products) | 28 | 20 |
| DRUP (Division of Reproductive and Urologic Products) | 16 | 6 |
| DSPTP (Division of Special Pathogen and Transplant Products) | 19 | 15 |
|
|
|
|
Numbers reflect the number of drugs (i.e., active moiety) per sponsor.
TOTAL Actions
307 Written Requests with PPSRs
71 Written Requests without PPSRs
280 Incomplete Responses
19 PPSR Withdrawal
7 Written Request Withdrawal
422 Written Request Amendments
TOTAL = 1106
*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.
-
-