[Federal Register Volume 70, Number 58 (Monday, March 28, 2005)]
[Notices]
[Page 15636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5974]


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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 PARAPLATIN 
(carboplatin), TRUSOPT (dorzolamide), CAMPTOSAR (irinotecan), PREVACID 
(lansoprazole), TAMIFLU (oseltamivir), VIOXX (rofecoxib), FERRLECIT 
(sodium ferric gluconate), IMITREX (sumatriptan), DETROL and DETROL LA 
(tolterodine). 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.
    In addition, the agency is also announcing the availability of 
summaries of medical and clinical pharmacology reviews of pediatric 
studies for the following antidepressants: CELAXA (citalopram), REMERON 
(mirtazapine), SERZONE (nefazodone), PAXIL (paroxetine), and ZOLOFT 
(sertraline). Studies for these drugs were submitted before the BPCA 
was implemented. Therefore, they are not subject to its requirements. 
However, due to the public's interest in these pediatric studies, FDA 
asked the sponsors to consent to the public disclosure of a summary of 
the medical and clinical pharmacology reviews for these studies. Based 
on sponsors' consent, FDA is making the summaries publicly available.

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. As discussed in 
greater detail in the following paragraphs, section 9 of the BPCA 
(Public Law 107-109) requires the disclosure of certain summaries of 
pediatric study reviews. In addition, based on the sponsors' consent, 
FDA is making available summaries of medical and clinical pharmacology 
reviews for pediatric studies of antidepressants submitted in response 
to a written request.
    The summaries of medical and clinical pharmacology reviews of 
pediatric studies conducted for PARAPLATIN (carboplatin), TRUSOPT 
(dorzolamide), CAMPTOSAR (irinotecan), PREVACID (lansoprazole), TAMIFLU 
(oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate), 
IMITREX (sumatriptan), DETROL and DETROL LA (tolterodine) are being 
made available consistent with section 9 of the BPCA. 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 (http://www.fda.gov/cder/pediatric/index.htm) summaries of medical and 
clinical pharmacology reviews of pediatric studies submitted in 
supplements for PARAPLATIN (carboplatin), TRUSOPT (dorzolamide), 
CAMPTOSAR (irinotecan), PREVACID (lansoprazole), TAMIFLU (oseltamivir), 
VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate), IMITREX 
(sumatriptan), DETROL and DETROL LA (tolterodine). Copies are also 
available by mail (see ADDRESSES).
    In addition, the agency is also announcing the availability of 
summaries of medical and clinical pharmacology reviews of pediatric 
studies for the following antidepressants: CELAXA (citalopram), REMERON 
(mirtazapine), SERZONE (nefazodone), PAXIL (paroxetine), and ZOLOFT 
(sertraline). Section 9 of the BPCA does not require the disclosure of 
these summaries. However, due to the public's interest in these 
studies, FDA asked the sponsors to consent to the public disclosure of 
the summaries of the medical and clinical pharmacology reviews. Based 
on the sponsors' consent, FDA is making the reviews publicly available 
on the Internet (http://www.fda.gov/cder/pediatric/index.htm) and 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: March 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5974 Filed 3-25-05; 8:45 am]
BILLING CODE 4160-01-S