Feature | May 17, 2012| Dave Fornell

FDA Approves Generic Versions of Blood Thinner Plavix

Generic clopidogrel expected to cut medical costs for cardiac patients

May 17, 2012 — The U.S. Food and Drug Administration (FDA) today approved generic versions of the blood-thinning drug Plavix (clopidogrel), which is expected to have a major impact on the cost to treat patients at risk of heart attack and stroke.

The drug is one of the most widely used pharmaceuticals. Although newer drugs have been introduced to compete against clopidogrel, the agent has remained the No. 1 selling antiplatelet agent. That dominance is expected to become stronger with the drug going generic and slashing its cost.

Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva Pharmaceuticals have gained FDA approval for 300 milligram (mg) clopidogrel. Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.

Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.

The agent helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries. The agent is also used in conjunction with surgical and interventional coronary disease therapies.

“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients.”

One issue with the drug is that up to one-third of patients cannot metabolize it. For this reason, clopidogrel has a boxed warning to alert healthcare professionals and patients that the drug may not work well for those with certain genetic factors. Tests are available to see if a patient will respond or not. For non-responders, newer drugs are available that are metabolized differently.

Clopidogrel also interacts with some medications, especially proton pump inhibitors such as Prilosec (omeprazole) and Nexium (esomeprazole). They can reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke.

For more information: www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Un...

Related Content

Edwards, Sapien 3 transcatheter heart valve, Canada, approval
News | Heart Valve Technology| July 27, 2016
Edwards Lifesciences Corp. announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for...
PCI outcomes, public reporting, high-risk patients, JAMA Cardiology, Beth Israel Deaconess Medical Center study
News | Cath Lab| July 27, 2016
July 27, 2016 — A number of states mandate public reporting of mortality outcomes following certain cardiac procedure
Abbott, Absorb bioresorbable stent, dissolving, UAB, University of Alabama at Birmingham, first in state
News | Stents Bioresorbable| July 26, 2016
On July 20, Massoud Leesar, M.D., of University of Alabama at Birmingham Hospital implanted a patient with Absorb, the...
CMS, Overall Hospital Quality Star Rating, national distribution, quailty of care
News | Business| July 26, 2016
July 25, 2016 — The Centers for Medicare and Medicaid Services (CMS) announced that it expects to launch its new Over
News | Antiplatelet and Anticoagulation Therapies| July 26, 2016
July 26, 2016 — Hematology researchers at The Children’s Hospital of Philadelphia (CHOP) have developed a novel genet
pros and cons of new anticoagulation therapies, anticoagulants, dabigatran, Pradaxa, novel oral anticoagulants, NOACs, rivaroxaban, Xarelto, apixaban, Eliquis
Feature | Antiplatelet and Anticoagulation Therapies| July 26, 2016 | Heidi Olson, Pharm.D
With the recent introduction of several novel oral...
Stryker Sustainability Solutions, Angiodynamics Soft Vu Omni Flush Angiographic Catheters, recall
News | Angiographic Catheter| July 25, 2016
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush...
Million Hearts Cardiovascular Disease Risk Reduction Model, CMS, reduce heart attacks and strokes, participants
News | Patient Engagement| July 22, 2016
July 22, 2016 — The Centers for Medicare & Medicaid Services (CMS) recently announced 516 awardees in 47 states,
heart failure, after first heart attack, cancer risk, JACC study
News | Cardiac Diagnostics| July 21, 2016
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared...
Absorb, bioresorbable stent, BVS

The Abbott Absorb stent gained FDA clearance in July 2016. It has metallic markers at each end so it can be visualized for proper positioning under angiographic X-ray imaging. 

Feature | Stents Bioresorbable| July 21, 2016 | Alphonse Ambrosia, D.O.
Some have labeled bioresorbable scaffolds (BRS), also known as bioresorbable stents, as the fourth evolution of inter
Overlay Init