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Notice

Oncologic Drugs Advisory Committee; Amendment of Notice

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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.

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Dated: September 2, 2009.

David Horowitz,

Assistant Commissioner for Policy.

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[FR Doc. E9-21556 Filed 9-8-09; 8:45 am]

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