[Federal Register: April 15, 2004 (Volume 69, Number 73)]
[Notices]
[Page 20012-20013]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap04-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0158]
Referral of ZONEGRAN (Zonisamide), WELLBUTRIN and ZYBAN
(Bupropion), and RENAGEL (Sevelamer) for the Conduct of Pediatric
Studies
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
referral of ZONEGRAN (zonisamide), WELLBUTRIN and ZYBAN (bupropion),
and RENAGEL (sevelamer) to the Foundation for the National Institutes
of Health (the Foundation) for the conduct of pediatric studies. FDA
referred these drugs to the Foundation on November 14, 2003, and is
publishing this notice of the referrals.
FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug
Evaluation and Research (HFD-960), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7777.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 4 of the BPCA (Public Law 107-109), FDA
is announcing the referral to the Foundation of the written requests
for the conduct of pediatric studies for ZONEGRAN (zonisamide),
WELLBUTRIN and ZYBAN (bupropion), and RENAGEL (sevelamer). Enacted on
January 4, 2002, the BPCA reauthorizes, with certain important changes,
the exclusivity incentive 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 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.
The BPCA established additional mechanisms for obtaining
information on the safe and effective use of drugs in pediatric
patients. Specifically, section 4 of the BPCA amends section 505A(d) of
the act to create a referral process to obtain studies for drugs that
have patent or exclusivity protection, but for which the sponsor has
declined to conduct the pediatric studies in response to a written
request by FDA. Under section 4 of the BPCA, if the Secretary of Health
and Human Services (the Secretary) determines that there is a
continuing need for the pediatric studies described in the written
request and the sponsors of the products with patent or exclusivity
protection have declined to conduct the studies, the Secretary shall
refer the drug to the Foundation, established under section 499 of the
Public Health Service Act (42 U.S.C. 290(b)), for the conduct of the
pediatric studies described in the written request (21 U.S.C.
355a(d)(4)(B)(i)). In addition, the BPCA requires public notice of the
name of the drug, name of the manufacturer, and indications to be
studied pursuant to the referrals.
In accordance with section 4 of the BPCA, FDA is announcing that it
has referred the written request for pediatric studies for ZONEGRAN
(zonisamide), WELLBUTRIN and ZYBAN (bupropion), and RENAGEL (sevelamer)
to the Foundation. On July 3, 2002, FDA issued a written request for
pediatric studies to Elan Pharmaceuticals, the holder of approved
applications for ZONEGRAN (zonisamide) that have market exclusivity.
The studies described in the written request were for adjunctive
therapy in the treatment of partial seizures in the pediatric
population. Elan Pharmaceuticals declined to conduct the requested
studies. FDA has determined that there is a continuing need for
information relating to the use of ZONEGRAN (zonisamide) in the
pediatric population.
On July 2, 2002, FDA issued a written request for pediatric
studies to GlaxoSmithKline, the holder of approved applications for
orally
[[Page 20013]]
administered WELLBUTRIN and ZYBAN (bupropion) that have market
exclusivity. The studies described in the written request were for the
indications of depression and smoking cessation in the pediatric
population. GlaxoSmithKline declined to conduct the requested studies.
FDA has determined that there is a continuing need for information
relating to the use of WELLBUTRIN and ZYBAN (bupropion) in the
pediatric population.
On July 3, 2002, FDA issued a written request for pediatric studies
to GelTex Pharmaceuticals, the holder of approved applications for
RENAGEL (sevelamer) that have market exclusivity. The studies described
in the written request were for the indication of hyperphosphatemia in
the pediatric population. GelTex Pharmaceuticals declined to conduct
the requested studies. FDA has determined that there is a continuing
need for information relating to the use of RENAGEL (sevelamer) in the
pediatric population.
Consistent with the provisions of the BPCA, on November 14, 2003,
FDA referred to the Foundation the written requests for the conduct of
the pediatric studies for ZONEGRAN (zonisamide), WELLBUTRIN and ZYBAN
(bupropion), and RENAGEL (sevelamer).
Dated: April 7, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8514 Filed 4-14-04; 8:45 am]
BILLING CODE 4160-01-S