|
Pediatric Exclusivity Statistics
as of December 31, 2008
| Review Division |
Proposed Pediatric Study Requests (PPSRs) Received |
Written Requests Issued * |
| DCRP (Division of Cardiovascular Rental Drug Products) |
51 |
36 |
| DNP (Division of Neurology Products |
66 |
45 |
| DPP (Division of Psychiatry Products) |
15 |
6 |
| DDOP (Division of Drug Oncology Products) |
38 |
40 |
| DMIHP (Division of Medical Imaging and Hematology Products) |
14 |
6 |
| DAARP (Division of Analgesics, Anesthetics, and Rheumatology Products) |
60 |
32 |
| DGP (Division of Gastroentereology Products) |
49 |
20 |
| DMEP (Division of Metabolism and Endocrinology Products) |
102 |
42 |
| DAIOP (Division of Anti-Infective and Ophthalmology Products) |
29 |
34 |
| 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 |
19 |
| DRUP (Division of Reproductive and Urologic Products) |
16 |
6 |
| DSPTP (Division of Special Pathogen and Transplant Products) |
20 |
15 |
| TOTAL |
566
|
360
|
Numbers reflect the number of drugs (i.e., active moiety) per sponsor.
TOTAL Actions
292 Written Requests with PPSRs
68 Written Requests without PPSRs
271 Incomplete Responses
19 PPSR Withdrawal
7 Written Request Withdrawal
413 Written Request Amendments
TOTAL = 1070
*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.
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Date created: August 4, 2005; Last updated: January 13, 2008 |
