Novartis receives FDA approval for LESCOL XL 80 mg

New Formulation Provides Effective Treatment for Patients with Cholesterol, Triglyceride and other Lipid Disorders

EAST HANOVER, New Jersey - Novartis Pharmaceuticals Corporation today announced approval by the U.S. Food and Drug Administration for LESCOL XL (fluvastatin sodium) 80 mg, an extended-release tablet formulation of fluvastatin, a therapy that provides effective management of all major lipid parameters for patients with a variety of lipid disorders that place them at risk for heart disease. Phase III clinical trials demonstrate that LESCOL XL 80 mg produced up to 38 percent median decrease in low-density lipoprotein cholesterol (LDL-C) in patients with dyslipidemia, and a 25 percent median decrease in triglycerides (TG) and a 13 percent mean increase in high-density lipoprotein cholesterol (HDL-C) in patients with primary mixed dyslipidemia (Fredrickson Type IIb), as compared with LESCOL (fluvastatin sodium) 40 mg therapy.

"Physicians can use LESCOL XL as a starting dose to help patients effectively manage all major lipid parameters," said Paulo Costa, president and chief executive officer, Novartis Pharmaceuticals Corporation. "Phase III data demonstrate that this new formulation has the potential to bring the majority of patients who require statin therapy to their treatment goals."

For patients who have lipid disorders that place them at risk for heart disease, more than 90 percent can meet their treatment goals, as defined by the clinical application of the National Cholesterol Education Program (NCEP), by achieving a reduction of less than 30 percent in their LDL-C levels, according to empirical data from the National Health and Nutrition Examination Survey (NHANES III). The National Heart, Lung, and Blood Institute created the NCEP to contribute to reducing illness and death from coronary heart disease in the United States by reducing the percent of Americans with high blood cholesterol.


Contact: Anna Frable
Porter Novelli

Page: 1 2 3

Related medicine news :

1. Novartis announces collaboration with Bayer for EMSELEX
2. Dr. Judah Folkman honored with American Heart Association/Novartis award
3. Drs. Gerald DiBona and John Hall receive American Heart Association/Novartis award
4. Novartis receives FDA approval for Starlix, a new treatment for type 2 diabetes
5. UIC professor receives international humanitarian award
6. Mailman School of Public Health receives Manhattan Tobacco Cessation Center grant
7. Epidemiologist Trichopoulos receives $5.8 million Department of Defense Innovator Award
8. GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix
9. NYU Child Study Center receives grant from the American Red Cross September 11 recovery program
10. Northwestern Memorial Hospital receives $10 million commitment to support preeminent heart program
11. American Academy of Neurology program receives Grassroots Award

Post Your Comments:

(Date:3/22/2020)... CHARLOTTESVILLE, Va. (PRWEB) , ... March 21, 2020 ... ... Modular Building Institute (MBI) and the Modular Home Builders Association (MHBA), have been ... response efforts. , MHBA has been advocating for greater use of modular ...
(Date:3/22/2020)... ... March 21, 2020 , ... TriageLogic, a leader ... medical organizations, and health centers can use for patient care during the COVID-19 ... medical professionals are working around the clock to implement emergency support solutions for ...
(Date:3/22/2020)... (PRWEB) , ... March 22, 2020 , ... ... self-awareness and mindfulness may appear to be a frivolous luxury. The world’s focus ... and trying to find some sense of stability and control in chaos. However, ...
(Date:3/20/2020)... ... March 20, 2020 , ... CommunityMed Urgent Care , based in Dallas, ... waiting room lets patients present online, complete registration paperwork (including the latest COVID screening) ... turn, and get signaled that their clean exam room is ready. All of ...
(Date:3/20/2020)... WILMINGTON, Del. (PRWEB) , ... March 21, 2020 ... ... from the healthcare and legal communities together for a day of live discussion ... topics including patient advocacy and ethics, telemedicine, whistleblower laws, the role of boards, ...
Breaking Medicine News(10 mins):
(Date:3/27/2020)... Wash. (PRWEB) , ... March 27, 2020 , ... ... an online college recruitment platform based on students' holistic portfolios, revealed that college-bound ... COVID-19 pandemic. This pandemic is creating huge new barriers to high school senior’s ...
(Date:3/22/2020)... ... March 21, 2020 , ... As the spread of Coronavirus ... of Thoracic Medicine and Surgery, and the Temple Lung Center have taken proactive ... tracking platform and triage/care coordination services. Temple is now enrolling patients, faculty, staff, ...
(Date:3/20/2020)... ... March 20, 2020 , ... Users who have tested positive for ... a crowd-sourced database of detailed location information, such as a specific building on campus ... or exposure to the virus. The app will also help people to more easily ...
Breaking Medicine Technology:
Cached News: