Navigation Links
FDA Approves Generic Versions of Plavix
Date:5/18/2012

By Steven Reinberg
HealthDay Reporter

THURSDAY, May 17 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved generic versions of the blood thinner Plavix (clopidogrel), making the widely used medication more affordable for those patients who need it.

"For people who must manage chronic health conditions, having effective and affordable treatment options is important. The generic products approved today will expand those options for patients," Keith Webber, deputy director of the Office of Pharmaceutical Sciences in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

A cardiology expert applauded the move.

Adherence rates will improve as a result of the lower-priced generic versions, and fewer patients will suffer from preventable cardiovascular problems, said Dr. Gregg Fonarow, director of the Ahmanson-UCLA Cardiomyopathy Center in Los Angeles.

"This medication has helped millions of patients avoid fatal and nonfatal cardiovascular events," said Fonarow, who also is a spokesman for the American Heart Association. But its high cost has "contributed to patients not filling initial prescriptions for the drug and premature discontinuation of clopidogrel," he said.

Patients who stop taking the drug prematurely may face catastrophic consequences, including fatal cardiovascular events and strokes, he added.

Sales of Plavix, made by Bristol-Myers Squibb, topped $9 billion in 2011. A generic version, at a much lower cost, is expected to eat into those sales dramatically. The drug already is sold as a generic by Sanofi in much of the European Union, according to the Associated Press.

The cost of Plavix was almost $200 a month, according to published reports. The generic versions are expected to cost much less.

Clopidogrel works by helping prevent platelets in the blood from sticking together to form clots. The drug usually is taken along with aspirin, which acts as a blood thinner to prevent heart attack and stroke.

Clopidogrel is commonly used by patients with heart-related chest pain, unstable heart disease or those who have had a stent implanted to open a blocked artery.

Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals won FDA approval Thursday for their generic versions of 300 milligram (mg) Plavix.

Apotex Corp., Aurobindo Pharma, Roxane Laboratories, Sun Pharma, Torrent Pharmaceuticals, Mylan and Teva won approval for lower-dose versions (75 mg), the FDA added.

"The most important impact of the availability of generics will be to reduce costs for patients and health systems where clopidogrel is already indicated," said Dr. Ralph Sacco, chairman of neurology at the University of Miami School of Medicine and former president of the American Heart Association.

The drug doesn't work for everyone, however. Some patients can't metabolize it, which reduces its effectiveness.

In addition, new drugs are available that may be better than clopidogrel, Fonarow said.

"Newer antiplatelet agents, such as prasugrel [Effient] and ticagrelor [Brilinta], have been shown to be more effective] than clopidogrel, and for many patients these [drugs] may be a better choice, despite higher cost," Sacco said.

Plavix, even in a less expensive version, can't replace other clot-preventing drugs, such as warfarin, in certain patients.

For example, Plavix is not recommended for patients with an irregular heartbeat, called atrial fibrillation, who take blood thinners to prevent strokes. A 2009 report in the New England Journal of Medicine said patients with atrial fibrillation who took Plavix were at an unacceptably high increased risk of severe bleeding.

More information

For more information on clopidogrel, visit the U.S. National Institutes of Health.

SOURCES: Ralph Sacco M.D., chairman, neurology, University of Miami Miller School of Medicine, and former president, American Heart Association; Gregg Fonarow, M.D., professor, medicine, director, Ahmanson-UCLA Cardiomyopathy Center, and co-director, University of California-Los Angeles Preventative Cardiology Program; Associated Press; May 17, 2012, news release, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA approves new skin cancer drug first tested in Arizona by Scottsdale Healthcare and TGen
2. FDA Approves First Combo Drug for Diabetes, Cholesterol
3. FDA Approves Novel Melanoma Drug
4. FDA Approves Blood Thinner Brilinta for Heart Patients
5. FDA Approves Test That Spots Aggressive Breast Cancer
6. FDA Approves Test That Spots HER2-Positive Breast Cancers
7. FDA Approves Another New Drug to Fight Hepatitis C
8. FDA approves new drug for advanced melanoma
9. FDA approves ipilimumab, an immunotherapy, to treat metastatic melanoma
10. FDA Approves 1st New Lupus Drug in More Than 50 Years
11. FDA Approves First 3D Mammogram Device
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves Generic Versions of Plavix 
(Date:10/13/2017)... ... October 13, 2017 , ... ... communities in the greater Dallas, Miami, and Raleigh regions, is organizing an extended ... overcome a rare and deadly chromosome abnormality. , After struggling since birth with ...
(Date:10/13/2017)... ... 13, 2017 , ... The International Association of Eating Disorders ... for the field of eating disorders, announces the opening of early registration for ... Florida at the Omni Resort at ChampionsGate. , The annual iaedp™ ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Many families ... However, many long-term care insurance companies have a waiver for care if the client ... elimination period, when the family pays for care, is often waived, so the benefits ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor ... on sciatica in a new episode of "Success Files," which is an award-winning ... innovation and investigates each subject in-depth with passion and integrity. , Sciatica occurs ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... 27, 2017  Commended for their devotion to personalized service, ... as number one in the South Florida Business Journal,s 50 ... 5000 yearly list, the national specialty pharmacy has found its ... will soon be honored by SFBJ as the 2017 ... Set to receive his award in October, Bardisa said ...
(Date:9/25/2017)... 2017  EpiVax, Inc., a leader in the ... today announced the launch of EpiVax Oncology Inc., ... therapeutic cancer vaccines. EpiVax has provided $500,000 in ... enabling technologies to the new precision immunotherapy venture. ... Oncology as Chief Executive Officer. Gad brings over ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical (AVACEN) ... is now successfully helping those with the widespread pain ... Fibromyalgia diagnosed Amanda in Essex, England ... washing my hair, experiencing no sleep at all, tremendous ... spasm… I cannot recommend [the AVACEN 100] enough, how ...
Breaking Medicine Technology: