May 17, 2012 — The US Food and Drug Administration (FDA) has approved 2 generic versions of the ubiquitous anticoagulant clopidogrel (Plavix, Bristol-Meyers Squibb/Sanofi), the agency announced today. Nine pharmaceutical companies are lined up to turn them out.

The FDA cleared Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals to produce a 300-mg version of clopidogrel. Teva and Mylan also gained approval along with Apotex, Aurobindo Pharma, Roxane Laboratories, Sun Pharma, and Torrent Pharmaceuticals to make a 75-mg version.

One of the world's best-selling drugs, clopidogrel is indicated for patients who have had a recent heart attack or stroke or who have peripheral artery disease or acute coronary syndrome.

A boxed warning on the label advises clinicians that the drug's effectiveness may decrease in patients with impaired metabolism, which can be identified through genetic testing. The proton pump inhibitors omeprazole (Prilosec, Procter & Gamble) and esomeprazole (Nexium, AstraZeneca) also can reduce the efficacy of clopidogrel. Bleeding (sometimes fatal) is the most commonly reported adverse event.

More information on today's FDA announcement is available on the agency's Web site.