[Federal Register Volume 64, Number 37 (Thursday, February 25, 1999)]
[Notices]
[Page 9334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Endocrinologic and Metabolic Drugs Advisory Committee; Amendment 
of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Endocrinologic and Metabolic 
Drugs Advisory Committee Meeting that is scheduled for March 26, 1999. 
This meeting was announced in the Federal Register of February 8, 1999 
(64 FR 6100). The amendment is being made to reflect a change in the 
agenda of the meeting notice. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Kathleen R. Reedy or LaNise Giles, 
Center for Drug Evaluation and Research (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 12536.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 8, 1999 
(64 FR 6100), FDA announced that the meeting of the Endocrinologic and 
Metabolic Drugs Advisory Committee would discuss experience since 
approval for marketing, benefits, and risks of RezulinTM 
(troglitazone, Parke-Davis Pharmaceutical Research, a Division of 
Warner-Lambert) in the treatment of type 2 diabetes mellitus. This 
amendment is being made to provide new information regarding the agenda 
of the meeting. On page 6100, in the third column, the Agenda is 
amended to read as follows:
    Agenda: The committee will discuss: (1) Experience since approval 
for marketing, benefits, and risks of RezulinTM 
(troglitazone, Parke-Davis Pharmaceutical Research, a Division of 
Warner-Lambert) in the treatment of type 2 diabetes mellitus; and (2) 
new drug application 20-720; S12 RezulinTM for triple 
therapy with sulfonylurea and metformin in the treatment of type 2 
diabetes mellitus.

    Dated: February 16, 1999.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 99-4611 Filed 2-24-99; 8:45 am]
BILLING CODE 4160-01-F