Pediatric Exclusivity Statistics
as of April 30, 2009
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 |
67 |
45 |
DPP (Division of Psychiatry Products) |
15 |
8 |
DDOP (Division of Drug Oncology Products) |
39 |
41 |
DMIHP (Division of Medical Imaging and Hematology Products) |
16 |
7 |
DAARP (Division of Analgesics, Anesthetics, and Rheumatology Products) |
59 |
35 |
DGP (Division of Gastroentereology Products) |
48 |
21 |
DMEP (Division of Metabolism and Endocrinology Products) |
103 |
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 |
TOTAL |
569
|
370
|
Numbers reflect the number of drugs (i.e., active moiety) per sponsor.
TOTAL Actions
301 Written Requests with PPSRs
69 Written Requests without PPSRs
273 Incomplete Responses
19 PPSR Withdrawal
7 Written Request Withdrawal
416 Written Request Amendments
TOTAL = 1083
*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: May 7, 2009 |