[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Page 16977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8501]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting is
open to the public.
Name of Committee: Peripheral and Central Nervous System Drugs
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 28 and 29, 1999,
8:30 a.m. to 5 p.m.
Location: Holiday Inn Gaithersburg, The Ballrooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Sandra Titus or Tony Slater, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-21), 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
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 12543. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On April 28, 1999, the committee will discuss the safety
and efficacy of new drug application (NDA) 20-884,
AggrenoxTM (dipyridamole/aspirin capsules, Boehringer
Ingelheim Pharmaceuticals, Inc.), proposed to reduce the combined risk
of death and nonfatal stroke in patients who have had transient
ischemia of the brain or completed ischemic stroke.
On April 29, 1999, the committee will discuss the safety and
efficacy of NDA 20-399, Freedox (tirilazad mesylate
injection, Pharmacia and Upjohn, Inc.), proposed for the treatment of
aneurysmal subarachnoid hemorrhage to improve survival and functional
outcome in patients with poor neurologic function following the initial
hemorrhage.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by April 21,
1999. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on April 28 and 29, 1999. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before April 21,
1999, and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 26, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-8501 Filed 4-6-99; 8:45 am]
BILLING CODE 4160-01-F
