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U.S. Department of Health and Human Services

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Federal Register Notice (71FR5667, issued 2/2/2006)

[Federal Register: February 2, 2006 (Volume 71, Number 22)]
[Notices]
[Page 5667]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02fe06-48]


[[Page 5667]]

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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 INVANZ (ertapenem),
KEPPRA (levetiracetam), TRILEPTAL (Oxcarbazepine), and ZYVOX
(linezolid). These summaries are being made available consistent with
the Best Pharmaceuticals for Children Act (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. 21, rm. 1613, Silver Spring, MD 20993-0002, 301-
796-2200, carmouzeg@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of summaries of medical and
clinical pharmacology reviews of pediatric studies conducted for INVANZ
(ertapenem), KEPPRA (levetiracetam), TRILEPTAL (Oxcarbazepine), and
ZYVOX (linezolid). 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 (21 U.S.C. 355a). Section 505A 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 INVANZ (ertapenem), KEPPRA (levetiracetam), TRILEPTAL
(Oxcarbazepine), and ZYVOX (linezolid). 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.


Dated: January 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1366 Filed 2-1-06; 8:45 am]

BILLING CODE 4160-01-S