Document ID: FDA-2009-N-0664-0082
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee; Amendment of Notice
Posted Date: 2009-09-09T04:00Z

[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]               
[Page 46435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Oncologic Drugs Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of a meeting of the Oncologic Drugs Advisory Committee. 
This meeting was announced in the Federal Register of August 25, 2009 
(74 FR 42907). The amendment is being made to reflect a change in the 
Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:  Nicole Vesely, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-6793, FAX: 301-827-6776, e-mail: 
nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512542. Please call the Information Line for up-to-date information 
on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 25, 2009, 
FDA announced that a meeting of the Oncologic Drugs Advisory Committee 
would be held on October 6, 2009. On page 42907, in the second column, 
the Agenda portion of the document is changed to read as follows:
    Agenda: The committee will discuss new drug application (NDA) 021-
825, with the proposed trade name FERRIPROX (deferiprone) film-coated 
tablets, manufactured by ApoPharma Inc. This product is an iron 
chelating agent, which is a drug that binds with iron in the body and 
helps to make elimination of iron easier, reducing iron build-up. There 
are two specific proposed indications (uses) of FERRIPROX: (1) For the 
treatment of iron overload, or build-up in patients with transfusion-
dependent thalassemia, an inherited blood disorder that necessitates 
frequent transfusion of normal blood which can lead to iron build-up 
due to the iron content in the blood a patient receives; and (2) for 
the treatment of iron overload in patients with other transfusion-
dependent anemias (other blood disorders that require frequent 
transfusions) for whom the use of other iron chelating agents has been 
considered inappropriate.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: September 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21556 Filed 9-8-09; 8:45 am]

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