[Federal Register Volume 69, Number 73 (Thursday, April 15, 2004)]
[Notices]
[Pages 20012-20013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8514]


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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