FDA approves generic versions of blood thinner Plavix

FDA has approved generic versions of clopidogrel tablets USP (Plavix, Sanofi and Bristol-Myers Squibb), 75 mg and 300 mg.

Plavix, which helps keep blood platelets from sticking together and forming clots, is approved to treat patients who have had a recent heart attack or a recent stroke, or who have partial or total blockage of an artery (peripheral artery disease).

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

Clopidogrel has a boxed warning to alert healthcare professionals and patients that the drug may not work well for those with certain genetic factors that affect how the body metabolizes the drug. Patients can be tested for these genetic factors to ensure that clopidogrel is the right choice for them. Also, certain medications, such as the proton pump inhibitors omeprazole (Prilosec) and esomeprazole (Nexium), reduce the effect of clopidogrel, leaving a person at greater risk for heart attack and stroke.

Clopidogrel may cause bleeding, which can be serious and sometimes lead to death. While taking the drug, people may bruise and bleed more easily, and they may be more likely to have nose bleeds; it may take longer for all bleeding to stop. Clopidogrel is dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300-mg clopidogrel. Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75-mg clopidogrel.

Plavix tablets (http://products.sanofi.us/plavix/plavix.html) 75 mg and 300 mg, had U.S. sales of approximately $6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.

According to David Calabrese, RPh, MHP, clinical editor of Drug Topics' sister publication Formulary and vice president, clinical operations, Med Metrics Health Partners, an SXC Company, “The introduction of generic clopidogrel, particularly recognizing its availability via multiple generic manufacturers, provides yet another welcome cost-savings opportunity for both payors and patients. This product joins a widening array of important new 2012 generic market entries, further driving value through more affordable, more accessible, and hopefully higher quality pharmaceutical care in higher-risk patient populations.”