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U.S. Department of Health and Human Services

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Federal Register Notice (69FR7761, issued 2/19/2004)

[Federal Register: February 19, 2004 (Volume 69, Number 33)]
[Notices]
[Page 7761-7762]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe04-67]

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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 Ciloxan
(ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent (fluticasone),
Fludara (fludarabine), Fosamax (alendronate), Lotensin (benazepril),
Malarone (atovaquone and proguanil), Xenical (orlistat), and Ocuflox
(ofloxacin ophthalmic). The summaries are being made available
consistent with section 9 of 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: The summaries are available for public examination between 9
a.m. and 4 p.m., Monday through Friday, in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. 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 N. Carmouze, Center for Drug
Evaluation and Research (HFD-960), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-7337,
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
Ciloxan (ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent
(fluticasone), Fludara (fludarabine), Fosamax (alendronate), Lotensin
(benazepril), Malarone (atovaquone and proguanil), Xenical (orlistat),
and Ocuflox (ofloxacin ophthalmic). 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

[[Page 7762]]

provision of the BPCA, FDA has posted on the Internet (http://www.fda.gov/cder/pediatric/index.htm
) summaries of medical and clinical

pharmacology reviews of pediatric studies submitted in supplements for
Ciloxan (ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent
(fluticasone), Fludara (fludarabine), Fosamax (alendronate), Lotensin
(benazepril), Malarone (atovaquone and proguanil), Xenical (orlistat),
and Ocuflox (ofloxacin ophthalmic). 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.


Dated: February 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3644 Filed 2-18-04; 8:45 am]

BILLING CODE 4160-01-S