69 FR 73 pgs. 20012-20013 - Referral of ZONEGRAN (Zonisamide), WELLBUTRIN and ZYBAN(Bupropion), and RENAGEL (Sevelamer) for the Conduct of PediatricStudies
Type: NOTICEVolume: 69Number: 73Pages: 20012 - 20013
Docket number: [Docket No. 2004N-0158]
FR document: [FR Doc. 04-8514 Filed 4-14-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 PediatricStudies
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing the referral of ZONEGRAN (zonisamide), WELLBUTRIN and ZYBAN(bupropion), and RENAGEL (sevelamer) to the Foundation for the NationalInstitutes of Health (the Foundation) for the conduct of pediatric studies.FDA referred these drugs to the Foundation on November 14, 2003, and ispublishing this notice of the referrals.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze,Center for Drug Evaluation and Research (HFD-960), Food and DrugAdministration, 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), FDAis announcing the referral to the Foundation of the written requests forthe conduct of pediatric studies for ZONEGRAN (zonisamide), WELLBUTRIN andZYBAN (bupropion), and RENAGEL (sevelamer). Enacted on January 4, 2002,the BPCA reauthorizes, with certain important changes, the exclusivityincentive program described in section 505A of the Federal Food, Drug, andCosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the act permitscertain applications to obtain 6 months of exclusivity if, in accordancewith the requirements of the statute, the sponsor submits requestedinformation relating to the use of the drug in the pediatricpopulation.
The BPCA established additional mechanisms for obtaining information onthe safe and effective use of drugs in pediatric patients. Specifically,section 4 of the BPCA amends section 505A(d) of the act to create areferral process to obtain studies for drugs that have patent orexclusivity protection, but for which the sponsor has declined to conductthe pediatric studies in response to a written request by FDA. Undersection 4 of the BPCA, if the Secretary of Health and Human Services (theSecretary) determines that there is a continuing need for the pediatricstudies described in the written request and the sponsors of the productswith patent or exclusivity protection have declined to conduct the studies,the Secretary shall refer the drug to the Foundation, established undersection 499 of the Public Health Service Act (42 U.S.C. 290(b)), for theconduct of the pediatric studies described in the written request (21U.S.C. 355a(d)(4)(B)(i)). In addition, the BPCA requires public notice ofthe name of the drug, name of the manufacturer, and indications to bestudied pursuant to the referrals.
In accordance with section 4 of the BPCA, FDA is announcing that it hasreferred the written request for pediatric studies for ZONEGRAN(zonisamide), WELLBUTRIN and ZYBAN (bupropion), and RENAGEL (sevelamer) tothe Foundation. On July 3, 2002, FDA issued a written request forpediatric studies to Elan Pharmaceuticals, the holder of approvedapplications for ZONEGRAN (zonisamide) that have market exclusivity. Thestudies described in the written request were for adjunctive therapy in thetreatment of partial seizures in the pediatric population. ElanPharmaceuticals declined to conduct the requested studies. FDA hasdetermined that there is a continuing need for information relating to theuse of ZONEGRAN (zonisamide) in the pediatric population.
On July 2, 2002, FDA issued a written request for pediatric studies toGlaxoSmithKline, the holder of approved applications for orally administered WELLBUTRIN and ZYBAN (bupropion) that have market exclusivity.The studies described in the written request were for the indications ofdepression and smoking cessation in the pediatric population.GlaxoSmithKline declined to conduct the requested studies. FDA hasdetermined that there is a continuing need for information relating to theuse of WELLBUTRIN and ZYBAN (bupropion) in the pediatric population.
On July 3, 2002, FDA issued a written request for pediatric studies toGelTex Pharmaceuticals, the holder of approved applications for RENAGEL(sevelamer) that have market exclusivity. The studies described in thewritten request were for the indication of hyperphosphatemia in thepediatric population. GelTex Pharmaceuticals declined to conduct therequested studies. FDA has determined that there is a continuing need forinformation relating to the use of RENAGEL (sevelamer) in the pediatricpopulation.
Consistent with the provisions of the BPCA, on November 14, 2003, FDAreferred to the Foundation the written requests for the conduct of thepediatric 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]
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