Navigation Links
Abbott's SIMCOR ® ( niacin extended-release / simvastatin ) Receives FDA Approval for New Dosage Strengths

ABBOTT PARK, Ill., July 28 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication.  The new SIMCOR dosage strengths combine 40 mg of simvastatin – the most commonly prescribed dose of simvastatin – with either 500 mg or 1,000 mg of niacin extended-release.  SIMCOR is the first treatment to combine Abbott's proprietary niacin extended-release and simvastatin, the most commonly used statin.  

SIMCOR is a prescription medication used along with diet in people who cannot control their cholesterol levels by diet and exercise alone.  SIMCOR is approved to raise HDL "good " cholesterol and lower levels of elevated total cholesterol, LDL " bad" cholesterol and triglycerides.  SIMCOR is a combination medicine used when treatment with simvastatin alone or niacin extended-release alone is not considered adequate.  No additional benefit of SIMCOR on heart disease over and above that shown for simvastatin alone and niacin alone has been demonstrated.  

"Approval of the new SIMCOR dosage strengths means that physicians and patients now have more options to treat complex lipid disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.  

SIMCOR was approved by the FDA in February 2008 in the following strengths: 500/20 mg, 750/20 mg and 1,000/20 mg.  The original FDA approval was supported by results from the SEACOAST trial, which demonstrated efficacy and safety of SIMCOR up to doses of 2,000 mg niacin extended-release / 40 mg simvastatin daily in patients with mixed dyslipidemia and type II hyperlipidemia.  The SIMCOR 40 mg strengths will be available in early August 2010.

Treatment guidelines endorsed by the National Cholesterol Education Program, the American College of Cardiology and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for some patients, as well as more aggressive management of HDL and triglycerides.

Important Safety Information About SIMCOR

SIMCOR should not be used by people with liver problems, stomach ulcers, or serious bleeding problems; in women who are pregnant, may become pregnant, or nursing.  Unexplained muscle pain, tenderness, or weakness may be a sign of a serious but rare muscle disorder, from which rare cases of death have occurred.  This risk of these muscle side effects is increased when SIMCOR is taken with certain types of medicines.  SIMCOR is associated with increases in liver enzymes as measured by blood tests.  Blood tests should be performed before and during treatment with SIMCOR to check for liver problems.  SIMCOR should be used with caution by patients who consume large amounts of alcohol.  SIMCOR may cause an increase in blood sugar levels which should be monitored closely in patients with diabetes.  

Flushing (warmth, redness, itching, and/or tingling of the skin) is a common side effect that may subside after several weeks of consistent use.  Other common side effects include headache, itching, nausea, back pain, and diarrhea.  

More information about SIMCOR, including full prescribing information, is available on the Web site, or by calling Abbott Medical Information at 1-800-633-9110.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.  The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at Media:

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New Data: Cholesterol Management Analysis of Upsher-Smiths Slo-Niacin(R) Tablets in Combination with Lipitor(R)
2. Slo-Niacin(R) Offers More Than 20 Years of Heart Health Support
3. New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV
4. UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets
5. Keppra XR(TM) Extended-Release Tablets Filed with the FDA
6. Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientific Session
7. Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder
8. New Data Highlight Positive Results of Namenda(R) (memantine HCl) Once-Daily Extended-Release Formulation
9. Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting
10. Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants
11. Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
Post Your Comments:
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... that was developed to enhance the health of felines. The formula is all-natural and ... main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... , ... Marcy was in a crisis. Her son James, eight, was out of control. Prone ... physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If ... at my other children and say he was going to kill them. If we ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):