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Pediatric Exclusivity Statistics    

As of October 31, 2004 

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

Review Division

Proposed Pediatric Study Requests (PPSRs) Received

Written Requests Issued *

Cardio-Renal Drug Products (HFD-110)

37

32

Neuropharmacological Drug Products (HFD-120)

50

40

Oncology Drug Products (HFD-150)

20

30

Medical Imaging and Radiopharmaceutical Drug Products (HFD-160)

4

0

Anesthetic, Critical Care, and Addiction Drug Products (HFD-170)

22

16

Gastro-Intestinal and Coagulation Drug Products (HFD-180)

32

20

Metabolic and Endocrine Drug Products (HFD-510)

59

38

Anti-Infective Drug Products (HFD-520)

5

2

Anti-Viral Drug Products (HFD-530)

25

29

Dermatologic and Dental Drug Products (HFD-540)

22

13

Anti-Inflammatory, Analgesic, and Ophthalmologic Drug Products (HFD-550)

33

39

Over-the-Counter Drug Products (HFD-560)

6

3

Pulmonary Drug Products (HFD-570)

17

17

Reproductive and Endocrine Drug Products (HFD-580)

11

3

Special Pathogen and Immunologic Drug Products (HFD-590)

16

13

TOTAL

359

295

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

TOTAL Actions

240 Written Requests with PPSRs

 55 Written Requests without PPSRs

172 Incomplete Responses

 12 PPSR Withdrawal

   7 Written Request Withdrawal

278 Written Request Amendments

TOTAL = 764

*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.    Back to top of table

 

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Last Updated: October 6, 2004