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U.S. Department of Health and Human Services

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Federal Register Notice (73FR12182, issued 3/6/2008)

[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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