Friday, December 27, 2013 3:23:27 PM
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...
The creation of a thousand forests is in one acorn.
Recent AMRN News
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/26/2024 12:00:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/24/2024 09:31:21 PM
- Amarin Chairman & CEO Issue Letter to Shareholders • GlobeNewswire Inc. • 01/22/2024 12:30:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM