FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dy... ( ...)

FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia

Date:8/3/2009

MONTGOMERY, Ala. and MORRISVILLE, N.C., Aug. 3 /PRNewswire/ -- Kowa Research Institute (KRI) based in Morrisville, NC and Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved LIVALO(R) (pitavastatin), a potent HMG-CoA reductase inhibitor (statin), for the primary treatment of hypercholesterolemia and combined dyslipidemia.

"The approval of LIVALO is a testament to the commitment and skill of Kowa's clinical development and regulatory groups in successfully bringing a new therapeutic option to a large, competitive market for cardiometabolic disorders," said Ben Stakely, CEO and President, KPA. "KPA is very pleased with the approval of LIVALO and is excited about the opportunity to introduce this new therapeutic option to physicians and patients."

"LIVALO has a robust safety, efficacy and tolerability profile and offers an attractive alternative for patients with primary hypercholesterolemia or combined dyslipidemia," said Antonio M. Gotto Jr., M.D., D.Phil, the Stephen and Suzanne Weiss Dean of Weill Medical College of Cornell University, New York. "LIVALO has very positive attributes that will help continue to fill current unmet needs in the statin market for clinically complex patient populations, such as the elderly, patients with diabetes or patients who take multiple medications for co-morbid conditions."

About LIVALO

LIVALO is a fully synthetic and highly potent statin engineered in Japan. LIVALO differs from other, currently available statins in the U.S. in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potential
'/>"/>

SOURCE Kowa Pharmaceuticals America, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4
Related medicine news :

1. FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
2. House Committee Approves Amendment Eliminating Cost-Sharing for Medicaid Preventive Services
3. FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension
4. FDA Approves Sculptra(R)Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles
5. Kaiser Permanente Approves $11 Million in Community Benefit Grants
6. FDA Approves Expanded Use of Lillys FORTEO(R) [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis
7. American Academy of Orthopaedic Surgeons approves new guideline for the treatment of pediatric diaphyseal femur fractures
8. American Academy of Orthopaedic Surgeons Approves New Guideline for the Treatment of Pediatric Diaphyseal Femur Fractures
9. FDA Approves VITROS(R) Anti-HCV Assay for Use On VITROS 5600(R) Integrated and VITROS 3600(R) Immunodiagnostic Systems
10. FDA Approves Seasonal Flu Vaccine for 2009-2010
11. FDA Approves Boston Scientifics TAXUS(R) Liberte(R) Long Stent

Post Your Comments:

(Date:3/21/2010)... March 21 Statement from Charmaine Yoest , President & CEO of Americans United for Life Action: , ... ... ... ... "This deal to pass the largest expansion of abortion since Roe v. Wade is ...

(Date:3/21/2010)... first time in humans, scientists used RNA to ... March 21 (HealthDay News) -- For the first ... gene-manipulation therapy to enter tumor cells and block ... cancer, researchers report. , "They,re basically putting ... don,t want this protein expressed for now," explained ...

(Date:3/18/2010)... , ... , ... ... WASHINGTON , March 18 Kids in New Jersey will take center stage in the fight against tobacco on ...

(Date:3/18/2010)... ,,, State Leaders Urged to Support Higher Tobacco Taxes, Other Tobacco Prevention Initiatives , ... , , ... ... WASHINGTON , March 18 ...

(Date:3/18/2010)... , ... ... WASHINGTON , March 18 The following is a statement by Cheryl G. Healton , Dr PH, President and CEO, Legacy(SM): , ... , , ...

Breaking Medicine News(10 mins):Health News:Gene-Targeted Cancer Fix Could Be a Breakthrough 2 Health News:Gene-Targeted Cancer Fix Could Be a Breakthrough 3 Health News:New Jersey Kids 'Kick Butts' on March 24 2 Health News:New Jersey Kids 'Kick Butts' on March 24 3 Health News:New Jersey Kids 'Kick Butts' on March 24 4 Health News:New Jersey Kids 'Kick Butts' on March 24 5 Health News:New Hampshire Kids 'Kick Butts' on March 24 2 Health News:New Hampshire Kids 'Kick Butts' on March 24 3 Health News:New Hampshire Kids 'Kick Butts' on March 24 4 Health News:Food and Drug Administration Issues Final Rule Regarding Sale, Distribution, and Use of Cigarettes and Smokeless Tobacco 2 Health News:Food and Drug Administration Issues Final Rule Regarding Sale, Distribution, and Use of Cigarettes and Smokeless Tobacco 3 Health News:Food and Drug Administration Issues Final Rule Regarding Sale, Distribution, and Use of Cigarettes and Smokeless Tobacco 4 Health News:Food and Drug Administration Issues Final Rule Regarding Sale, Distribution, and Use of Cigarettes and Smokeless Tobacco 5

[0] Yoest: Stupak Deal 'A Tragedy For America'[0] Gene-Targeted Cancer Fix Could Be a Breakthrough [0] New Jersey Kids 'Kick Butts' on March 24 [0] New Hampshire Kids 'Kick Butts' on March 24 [0] Food and Drug Administration Issues Final Rule Regarding Sale, Distribution, and Use of Cigarettes and Smokeless Tobacco

... ... nutrition curriculum, BENSENVILLE, Ill., Oct. 7 ... a comprehensive diet and,nutrition curriculum to all of its Head Start ... impact on lowering childhood,obesity and diabetes in minority children. Lifelink also ...

... Everything a Man Wanted to Know But Was Afraid ... are 4.3 million babies born,in the U.S. each year ... until,now. BEING DAD is a revealing, entertaining and inspirational ... fathers who,have recently gone through the pregnancy and delivery ...

... unlike vegetative state , , TUESDAY, Oct. 7 (HealthDay ... "minimally conscious state" may still feel pain and ... , A minimally conscious state (MCS) is different ... wakefulness without awareness of self or surroundings. MCS ...

... Oct. 7 The Catholic Health,Association of the ... Initiatives (CHI), Denver; Covenant Health Systems, Lexington, MA;,and ... ministry-wide effort to,raise awareness about global climate change., ... the National Religious,Partnership for the Environment (NRPE) and ...

... Articles on Breast Cancer and Shopping,Offers Benefitting Women ... BOOMj, Inc. (OTC,Bulletin Board: BOMJ) http://www.BOOMj.com, ... adults over the age of 35 today announced,its ... cancer., (Logo: http://www.newscom.com/cgi-bin/prnh/20070131/BOOMJLOGO ), ...

... 7 Stallergenes S.A.,today announced that they have ... promotion and distribution in Europe of adrenaline,autoinjector, ADREFLEX(R), ... PLC., ADREFLEX(R) consists of a syringe pre-filled ... paediatric use (0.3 and 0.15 mg), in an,autoinjector ...

Other Medicine News:Health News:DuPage's Only Provider of Head Start Takes Aim at Childhood Obesity in Minorities 2 Health News:DuPage's Only Provider of Head Start Takes Aim at Childhood Obesity in Minorities 3 Health News:BEING DAD DVD Offers a Sneak Peek at Pregnancy From a Guy's Point of View 2 Health News:Patients in Minimally Conscious State May Still Feel Pain 2 Health News:Catholic Health Organizations Launch Ministry-Wide Effort to Raise Awareness About Global Climate Change 2 Health News:BOOMj, Inc. Joins Fight Against Breast Cancer 2 Health News:BOOMj, Inc. Joins Fight Against Breast Cancer 3 Health News:Stallergenes Partners With Catalent and the Medical House for Commercialization of Adrenaline Autoinjector in Europe 2

DuPage's Only Provider of Head Start Takes Aim at Childhood Obesity in Minorities BEING DAD DVD Offers a Sneak Peek at Pregnancy From a Guy's Point of View Patients in Minimally Conscious State May Still Feel Pain Catholic Health Organizations Launch Ministry-Wide Effort to Raise Awareness About Global Climate Change BOOMj, Inc. Joins Fight Against Breast Cancer Stallergenes Partners With Catalent and the Medical House for Commercialization of Adrenaline Autoinjector in Europe

(Date:3/18/2010)... ,,,,, SILVER SPRING, Md. , March 18 The U.S. Food and Drug Administration today approved Carbaglu (carglumic acid) Tablets to treat a condition that results in too much ammonia in ... , ... ... (Logo: ...

(Date:3/18/2010)... ChemImage, a world leader in chemical imaging ... ingredient-specific particle sizing (ISPST) study on a combination Metered ... ( www.rddonline.com ). This conference will take place from ... Florida and will feature thought leaders discussing current ...

(Date:3/18/2010)... , March 18 Solos Endoscopy, Inc. ... has secured the U.S. Trademark for the MammoView® name. ... state-of-the-art endoscopic technology for detecting early stage breast cancer. ... and optical technology to give physicians sharp, clear images ...

[0] FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels [0] ChemImage's Raman Chemical Imaging Used for Ingredient-Specific Particle Sizing for Inhalation Product Development [0] Solos Endoscopy, Inc. Granted U.S. Trademark for MammoView(R)

... in Clinical Trials, SEATTLE, Sept. 9 ... in a Phase 1/Phase 2 study of OMS302, ... surgery. At least 60 patients undergoing age-related,cataract extraction ... the,study., "With the initiation of this study, ...

... FluoroPharma, Inc. announced today that,Dr. David Elmaleh, ... on two preclinical studies demonstrating the potential ... agents for detection,of Alzheimer,s disease (AD) and ... in Nice, France on September 10-13, 2008., ...

Other Medicine Technology:Omeros Announces Patient Enrollment in Phase 1/Phase 2 Study of OMS302 2 FluoroPharma, Inc. to Report Preclinical Data on Alzheimer's Disease and Prostate Cancer PET Imaging Agents 2 FluoroPharma, Inc. to Report Preclinical Data on Alzheimer's Disease and Prostate Cancer PET Imaging Agents 3

Omeros Announces Patient Enrollment in Phase 1/Phase 2 Study of OMS302 FluoroPharma, Inc. to Report Preclinical Data on Alzheimer's Disease and Prostate Cancer PET Imaging Agents

... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...

... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...

... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...

Medicine Products:

Scabies Arsenic Speciation, Inorganic, Urine Arsenic, Hair Aromatic Solvents, Whole Blood

FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dy...( ...),Health