Document ID: FDA-2008-N-0153-0001
Agency: fda
Document Type: Notice
Title: Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
Posted Date: 2008-03-06T05:00Z

[Federal Register: March 6, 2008 (Volume 73, Number 45)]
[Notices]               
[Page 12182-12183]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr08-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Summaries of Medical and Clinical Pharmacology Reviews of 
Pediatric Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of summaries of medical and clinical pharmacology reviews 
of pediatric studies submitted in supplements for BETOPTIC (betaxolol), 
LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL 
(risperidone), and TIMOLOL (timolol). These summaries are being made 
available consistent with the Best Pharmaceuticals for Children Act 
(the BPCA). For all pediatric supplements submitted under the BPCA, the 
BPCA requires FDA to make available to the public a summary of the 
medical and clinical pharmacology reviews of the pediatric studies 
conducted for the supplement.

ADDRESSES: Submit written requests for single copies of the summaries 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Please specify by product name which summary 
or summaries you are requesting. Send one self-addressed adhesive label 
to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries.

FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6460, Silver Spring, MD 20993-0002, 301-
796-0700, e-mail: grace.carmouze@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of medical and 
clinical pharmacology reviews of pediatric studies conducted for 
BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), 
RISPERDAL (risperidone), and TIMOLOL (timolol). The summaries are being 
made available consistent with section 9 of the BPCA (Public Law 107-
109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain 
important changes, the pediatric exclusivity program described in 
section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 355a). Section 505A of the act permits certain applications to 
obtain 6 months of marketing exclusivity if, in accordance with the 
requirements of the statute, the sponsor submits requested information 
relating to the use of the drug in the pediatric population.
    One of the provisions the BPCA added to the pediatric exclusivity 
program pertains to the dissemination of pediatric information. 
Specifically, for all pediatric supplements submitted under the BPCA, 
the BPCA requires FDA to make available to the public a summary of the 
medical and clinical pharmacology reviews of pediatric studies 
conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are 
to be made available not later than 180 days after the report on the 
pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent 
with this provision of the BPCA, FDA has posted on the Internet at 
http://www.fda.gov/cder/pediatric/index.htm summaries of medical and 
clinical pharmacology reviews of pediatric studies submitted in 
supplements for BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN 
(levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). Copies 
are also available by mail (see ADDRESSES).

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/pediatric/index.htm.

[[Page 12183]]

    Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4426 Filed 3-5-08; 8:45 am]

BILLING CODE 4160-01-S