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U.S. Department of Health and Human Services

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Federal Register Notice (72FR20344, issued 4/24/2007)

[Federal Register: April 24, 2007 (Volume 72, Number 78)]
[Notices]
[Page 20344-20345]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap07-56]

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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 CELEBREX (celecoxib),
COLAZAL (balsalazide), ELOXATIN (oxaliplatin), EMTRIVA (emtricitabine),
SUPRANE (desflurane), and TOPROL-XL (metoprolol). 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
CELEBREX (celecoxib), COLAZAL (balsalazide), ELOXATIN (oxaliplatin),
EMTRIVA (emtricitabine), SUPRANE (desflurane), and TOPROL-XL
(metoprolol). 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
summaries of medical and clinical pharmacology reviews of pediatric
studies submitted in supplements for CELEBREX (celecoxib), COLAZAL
(balsalazide), ELOXATIN (oxaliplatin), EMTRIVA (emtricitabine), SUPRANE
(desflurane), and TOPROL-XL (metoprolol). See the SUPPLEMENTARY
INFORMATION section for electronic access to the summaries. Copies are
also available by mail (see ADDRESSES).

[[Page 20345]]

II. Electronic Access

Persons with access to the Internet may obtain the summaries at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm.


Dated: April 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-7717 Filed 4-23-07; 8:45 am]

BILLING CODE 4160-01-S