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U.S. Department of Health and Human Services

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Federal Register Notice (70FR15636, issued 3/28/2005)

[Federal Register: March 28, 2005 (Volume 70, Number 58)]
[Notices]
[Page 15636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr05-52]

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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:
carmouzeg@cder.fda.gov.

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://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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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