80 FR 14139 - Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 52 (March 18, 2015)

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 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.

[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14139-14140]
From the Federal Register Online  [www.thefederalregister.org]
[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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