[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Pages 8460-8461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4078]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anti-Infective Drugs Advisory Committee Meeting; 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 Anti-Infective Drugs Advisory
Committee meeting. This meeting was announced in the Federal Register
of February 3, 1998 (63 FR 5562). The amendment is being made to
reflect a change in the agenda for the February 19, 1998, meeting day.
An additional indication for use in the treatment of infections caused
by Staphylococcus aureus will also be discussed. There are no other
changes. This amendment will be announced at the beginning of the open
portion of the meeting.
[[Page 8461]]
FOR FURTHER INFORMATION CONTACT: Ermona B. McGoodwin or Danyiel A.
D'Antonio, Center for Drug Evaluation and Research (HFD-21), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
5455, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-
443-0572 in the Washington, DC area), code 12530.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 3, 1998
(63 FR 5562), FDA announced that a meeting of the Anti-Infective Drugs
Advisory Committee would be held on February 19 and 20, 1998. This
amendment is to provide an update to the information provided earlier
pertaining to the February 19, 1998, meeting day. There are no changes
for the February 20, 1998, meeting day. On page 5562, in the second
column, the ``Agenda'' portion is amended to read as follows:
Agenda: On February 19, 1998, the committee will discuss new drug
applications 50-747 and 50-748 quinupristin/dalfopristin
(Synercid, Rhone-Poulenc Rorer Pharmaceuticals, Inc.) for use
in the treatment of vancomycin-resistant Enterococcus faecium (VREF)
infections, complicated skin and skin structure infections, community-
acquired pneumonia, hospital-acquired (nosocomial) pneumonia, and
infections caused by Staphylococcus aureus.
Dated: February 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-4078 Filed 2-18-98; 8:45 am]
BILLING CODE 4160-01-F
