[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14139-14140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06130]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Cardiovascular and Renal Drugs Advisory Committee; 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 Cardiovascular and Renal
Drugs Advisory Committee. This meeting was
[[Page 14140]]
announced in the Federal Register of February 27, 2015 (80 FR 10700).
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: Kristina Toliver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). Please call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 27,
2015, FDA announced that a meeting of the Cardiovascular and Renal
Drugs Advisory Committee would be held on April 15, 2015. On page
10700, in the first column, the Agenda portion of the document is
changed to read as follows:
The committee will discuss the new drug application (NDA) 204958,
cangrelor injection, submitted by The Medicines Company, for the
proposed indication of reduction of thrombotic cardiovascular events in
patients with coronary artery disease (CAD) undergoing percutaneous
coronary intervention (PCI)--(PCI refers to the opening of narrowed
blood vessels supplying the heart muscle by a balloon inserted through
an artery puncture with or without a stent) who have not received an
oral P2Y12 inhibitor prior to the PCI procedure and in whom oral
therapy with P2Y12 inhibitors is not feasible or desirable (P2Y12 is a
protein involved in blood clotting. Inhibiting this protein is a key
mechanism of action of cangrelor).
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: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06130 Filed 3-17-15; 8:45 am]
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