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/UnderstandingGenericDrugs/default.htm