[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Page 43440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14747]


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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 ADDERALL XR (mixed 
salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), 
AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). 
These 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: 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 (HFD-960), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-7337, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of summaries of medical and 
clinical pharmacology reviews of pediatric studies conducted for 
ADDERALL XR (mixed salts of a single-entity amphetamine product), 
AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and 
ZOFRAN (ondansetron). 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 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 ADDERALL XR (mixed salts of a single-entity amphetamine 
product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE 
(sirolimus), and ZOFRAN (ondansetron). 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: July 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14747 Filed 7-26-05; 8:45 am]
BILLING CODE 4160-01-S