Document

Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice

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...

[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

Legal Citation

Federal Register Citation

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64 FR 9334

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“Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice,” thefederalregister.org (February 25, 1999), https://thefederalregister.org/documents/99-4611/endocrinologic-and-metabolic-drugs-advisory-committee-amendment-of-notice.