Navigation Links
VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail Pharmacies
Date:4/16/2013

MOUNTAIN VIEW, Calif., April 16, 2013 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia® (phentermine and topiramate extended-release) capsules CIV. The amendment, submitted in October 2012, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.

"With FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system," said Peter Tam , president of VIVUS. "Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice.  We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage."

"The addition of certified retail pharmacies to the Qsymia network will reduce the prescribing burden for physicians and the waiting times for patients seeking to initiate therapy for obesity," said Barbara Troupin , MD, vice president, scientific communication and risk management, VIVUS. "While the Qsymia certified mail-order pharmacies will remain, the addition of retail availability will improve the overall physician and patient experience."

With this modification, the goals, commitments and components of the original Qsymia REMS will remain in place, including a Medicatio
'/>"/>

SOURCE VIVUS, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. VIVUS Announces New Qsymia Offer
2. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
3. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
4. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
5. Misonix Announces New Distribution Agreement For Panama
6. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
7. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
8. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
9. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
10. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
11. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... , July 11, 2014 ... "Scintillator Market by Composition of Material, Application (Healthcare, ... others), End Product (Personal Instrument, Hand-Held Instruments, Fixed, ... and Analysis to 2013 - 2020", published by MarketsandMarkets, the ... CAGR of 5.62% from 2014 to 2020, and ...
(Date:7/11/2014)... 2014  Australian drug delivery company, Phosphagenics Limited (ASX: ... A$19.3 million via a placement of A$16.3 million to ... U.S., Asia and ... purchase plan (SPP) to be offered to existing shareholders. ... two tranches. "This capital raising positions us ...
(Date:7/11/2014)... , July 11, 2014 Research and ... of the "Immunoprotein Diagnostic Testing Market - ... highest CAGR of 6% and is expected to ... to their offering. ... diagnostic testing has been segmented according to immunoprotein ...
Breaking Medicine Technology:Scintillator Market will be worth $479.16 Million by 2020 2Scintillator Market will be worth $479.16 Million by 2020 3Scintillator Market will be worth $479.16 Million by 2020 4Phosphagenics' A$19.3 million Capital Raising 2Phosphagenics' A$19.3 million Capital Raising 3Immunoprotein Diagnostic Testing Market - Forecasts to 2019: Expected to grow at the highest CAGR of 6% and is expected to be valued at USD 4,943.0 million 2
... for individuals living with West Nile Virus and ... or immune compromised, PURCHASE, N.Y., Sept. 9 ... State University supported by the Division of,Vector-Borne Infectious ... (CDC) has demonstrated that AHCC(R) (Active Hexose Correlated,Compound) ...
... SAN DIEGO, Sept. 9 Ardea Biosciences, Inc.,(Nasdaq: ... presented on,the Company,s lead mitogen-activated ERK kinase (MEK) inhibitor, ... at,the Gaylord Palms Resort & Convention Center in Orlando., ... follows:, Date/Time: Tuesday, October 7, 2008 from 10:30 ...
Cached Medicine Technology:Study Demonstrates That AHCC(R) Provides Immune Enhancement Against the West Nile Virus 2Study Demonstrates That AHCC(R) Provides Immune Enhancement Against the West Nile Virus 3Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at American College of Gastroenterology Annual Scientific Meeting 2
(Date:7/13/2014)... Recently, iFitDress.com, one of the most famous dress ... of brown evening dresses for worldwide clients. ... discounted prices, up to 50% off. , All ... are carefully made according to most fashionable styles. In ... offers pretty accessories: wedding shoes, dancing shoes, sandals, boots ...
(Date:7/13/2014)... a professional supplier of funeral products. According to the company’s ... the global market. Recently, the company has announced its latest ... offer for all the newly released items. , Despite ... made with superb materials. As is commonly noted, a nice ... the departed saint. MillionaireCasket.com is always here to help. , ...
(Date:7/13/2014)... the best treatment and variations in the quality of ... blood cancer patients still varies widely between regions within ... in European adults to date, published in The ... 5-year survival for most cancers of the blood has ... the approval of new targeted drugs in the early ...
(Date:7/13/2014)... County, NC (PRWEB) July 13, 2014 ... of its newest location, the Carolinas HealthCare System - ... facility replaces the aged Anson Community Hospital in Wadesboro. ... is approximately three miles from the previous facility. Situated ... single-story floorplan that includes an emergency room drop-off, helipad, ...
(Date:7/13/2014)... Nature Genetics identifies a novel genetic and ... esophagitis (EoE), opening up potential new therapeutic strategies ... , EoE is a chronic inflammatory disorder of ... hypersensitivity to certain foods and an over-accumulation in ... (part of the body,s immune system). EoE can ...
Breaking Medicine News(10 mins):Health News:2014 Brown Evening Dresses Added To iFitDress.com 2Health News:Brand New Cherry Caskets Unveiled By China Casket Supplier MillionaireCasket.com 2Health News:The Lancet Oncology: Differences in treatment likely to be behind differing survival rates for blood cancers between regions within Europe 2Health News:The Lancet Oncology: Differences in treatment likely to be behind differing survival rates for blood cancers between regions within Europe 3Health News:Carolinas HealthCare System - Anson Hospital Now Open 2Health News:Study finds cause of mysterious food allergy, suggests new treatment strategy 2Health News:Study finds cause of mysterious food allergy, suggests new treatment strategy 3
... since 1959 , , TUESDAY, Nov. 25 (HealthDay News) ... the risk of chronic obstructive pulmonary disease (COPD), which ... U.S. researchers studied the job and health records of ... who worked on diesel trains (engineers, brakemen, conductors) were ...
... Good(TM) Campaign Reaches $1 Million Dollar Donation Goal and Collects ... , , NEW YORK, Nov. ... pleased to announce the donation of one million dollars to ... Against Hunger. The donation was made possible by the ...
... officials,convened today at a briefing hosted by the Pittsburgh ... recommendations of the Southwestern,PA Regional HIV/AIDS Needs Assessment study. ... insight and perspective on the impact of,the assessment,s findings ... Kathi Boyle, Executive Director of Pittsburgh AIDS Task Force, ...
... Of all the threats facing U.S. soldiers in combat, ... improvised explosive devices (IED,s). At the 61st Meeting of ... week in San Antonio, Naval Research Laboratory (NRL) scientist ... risk of traumatic brain injury for U.S. soldiers and ...
... FRANCISCO, Nov. 25 ECO2 Plastics, Inc.,(OTC Bulletin Board: ... plastics are recycled, today announced that it has received ... Administration (FDA), which,affirms the effectiveness of its proprietary waterless ... recycled plastic flake,to be used in food packaging applications. ...
... Margins Shrunk; Nearly Half Lost Money , , ... - 47 percent - posted overall losses at the end of 2007, ... the New Jersey Hospital Association,s Financial Status of New Jersey Hospitals report. ... Jersey,s hospital industry was on shaky financial ground long before the recent ...
Cached Medicine News:Health News:Weight Watchers Members and Online Subscribers Lose an Estimated 4 Million Pounds in Six Week Period 2Health News:Weight Watchers Members and Online Subscribers Lose an Estimated 4 Million Pounds in Six Week Period 3Health News:Weight Watchers Members and Online Subscribers Lose an Estimated 4 Million Pounds in Six Week Period 4Health News:Experts Address State of HIV/AIDS Care in the Region Following Landmark Assessment Showing Widening Gaps in Social Services 2Health News:Experts Address State of HIV/AIDS Care in the Region Following Landmark Assessment Showing Widening Gaps in Social Services 3Health News:Experts Address State of HIV/AIDS Care in the Region Following Landmark Assessment Showing Widening Gaps in Social Services 4Health News:The physics of explosives and blast helmets 2Health News:The physics of explosives and blast helmets 3Health News:ECO2 Plastics, Inc. Receives Favorable FDA Opinion Letter Approving the Use of Its Recycled Plastic Flake in Food Packaging Applications 2Health News:ECO2 Plastics, Inc. Receives Favorable FDA Opinion Letter Approving the Use of Its Recycled Plastic Flake in Food Packaging Applications 3Health News:NJHA: Hospital Finances Show Troubling Trends 2
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of cardiac troponin I (cTnl) in human whole blood and serum specimens...
Medicine Products: