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Pediatric Advisory Committee

Amended Notice
To reflect a change in the Time and Agenda of the meeting.

Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).

Notice:
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of February 1, 2006 (71 FR 5343). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the meeting announcement.

Change: The starting time of the meeting has been moved to 7:30 a.m. and the committee will now also hear and discuss information on cardiovascular adverse events possibly related to ADHD medications. There are no other changes.

Supplementary Information:
In the Federal Register of February 1, 2006, FDA announced that a meeting of the Pediatric Advisory Committee would be held on March 22nd, 2006, from 8:00 a.m. to 6:00 p.m., and that the committee would receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications. On page 5343, 1st column, the Date and Time portion of the document is amended to read as follows:

Date and Time:
The meeting will be held on March 22, 2006, from 7:30 a.m. to 6:00 p.m.

On page 5343, 2nd column, the Agenda portion of the document is amended to read as follows:

Agenda:
The Pediatric Advisory Committee will hear and discuss a report by the agency, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports possibly related to clofarabine (CLOLAR), irbesartan (AVAPRO), sibutramine (MERIDIA), and the mixed salts amphetamine product (ADDERALL). In continuation of a prior committee discussion of adverse events for the class of methylphenidate products used to treat attention deficit hyperactivity disorder (ADHD), the committee will hear and discuss neuropsychiatric adverse events possibly related to other approved ADHD medications. The presentations will focus on neuropsychiatric adverse event reports and clinical trial data from approved ADHD medications. The committee will also hear and discuss information on cardiovascular adverse events possibly related to ADHD medications.

Contact Person:
Jan N. Johannessen, Office of Science and Health Coordination, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, Rm. 14C-06) Rockville, MD 20857, 301-827-6687, e-mail: Jan.Johannessen@fda.hhs.gov, or the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up to date information on this meeting.

[ Original Notice ]