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Friday, 12/27/2013 3:23:27 PM

Friday, December 27, 2013 3:23:27 PM

Post# of 423976
ACT NOW! Urge the FDA to Reinstate the ANCHOR SPA and Approve VASCEPA for Mixed Dyslipidemia

The FDA has heard the public outcry and is reviewing their decision to rescind the ANCHOR SPA, also the PDUFA date has been extended.

>> Important! Please comment on Citizen Petition from Thomas Ma MD PHD re EPA Drug Initiative at:

http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-1612-0005

>> ASAP Please write / fax letters to ALL the decision-makers (final decision on SPA appeal is due 15 Jan)

Pass this memo / information onto others!

Secretary Kathleen Sebelius
Department of Health and Human Services
200 Independence Avenue S.W.
Washington, D.C., 20201
Phone: (202) 690-7000

Dr. Margaret A. Hamburg
DHHS/FDA/OC
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Phone: (301) 796-5000

Curtis Rosebraugh, MD, MPH
Director
ODE-II, OND, CDER, FDA
10903 New Hampshire Avenue
Building WO22, Room 3214
Silver Spring MD 20993-0002
Phone 301-796-2310
Fax 301-796-9717

Jean –Marc Guettier, MD
Director
DMEP, ODE-II, OND, CDER, FDA
10903 New Hampshire
Silver Spring, MD 20993
Phone 301-796-4958

Eric Colman, MD
Deputy Director
DMEP, ODE-II, OND, CDER, FDA
10903 New Hampshire
Silver Spring, MD 20993
Phone: 301-796-1190
Fax: 301-796-9712

James P. Smith, MD, MS
Clinical Team Leader
DMEP, ODE-II, OND, CDER, FDA
10903 New Hampshire
Silver Spring, MD 20993
Phone: 301-796-1317

Mary Dunne Roberts, MD
Clinical Reviewer
DMEP, ODE-II, OND, CDER, FDA
10903 New Hampshire
Silver Spring, MD 20993
Phone: 301-796-4088

Mary H. Parks
Supervisory Medical Officer
10903 New Hampshire
Silver Spring, MD 20993
Phone: 301-796-2290
Fax: 301-796-9712

Please do not ignore this plea for your continued support.
Comments to the Citizen Petition are important, as are any letters you may write. Ask others to write letters / advocate.

Reference: FDA Review of sNDA 202057/S-005, Vascepa (icosapent ethyl) Capsules

Thank you...

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