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Pediatric Exclusivity Statistics

Posted Jun 09 2010 8:00am

as of May 31, 2010

Review Division Proposed Pediatric Study Requests (PPSRs) Received Written Requests Issued *
DCRP (Division of Cardiovascular Renal Drug Products) 52 38
DNP (Division of Neurology Products  69 45
DPP (Division of Psychiatry Products)  22 Updated 11 Updated
DDOP (Division of Drug Oncology Products) 49 Updated 50 Updated
DHP (Division of Hematology Products) 17 7
DAAP (Division of Analgesics and Anesthetics Products)  62 36
DGP (Division of Gastroentereology Products)  50 21
DMEP (Division of Metabolism and Endocrinology Products) 104  43 Updated
DAIOP (Division of Anti-Infective and Ophthalmology Products)  31 35
DAVP (Division of Anti-Viral Products)  34 41 ** Updated
DDDP (Divisioin of Dermatology and Dental Drug Products)  38 17
DNCE (Division of Nonprescription Evaluation)   8 5
DMIP (Division of Medical Imaging Products) - -
DNRD (Division of Nonprescription Regulation Development) - -
DPARP (Division of Pulmonary, Allergy and Rheumatology Products) 28 20
DRUP (Division of Reproductive and Urologic Products) 17 6
DSPTP (Division of Special Pathogen and Transplant Products) 20 16
 601 Updated
391 Updated

Numbers reflect the number of drugs (i.e., active moiety) per sponsor.

TOTAL Actions

319  Updated Written Requests with PPSRs

  72  Written Requests without PPSRs

298  Updated Incomplete Responses  

  20  PPSR Withdrawals

    8  Updated Written Request Withdrawals

436  Updated Written Request Amendments

TOTAL = 1153 Updated

  *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.

** TMC278 (7-3-08) & nevirapine (3-26-10) WRs added to count - never received prior to May

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