Eliquis is manufactured by Bristol-Myers Squibb and co-marketed with Pfizer. Both companies are based in New York.
The FDA said it approved the drug based on an 18,000-patient study conducted by the drugmakers. The trial showed that patients taking Eliquis had fewer strokes than those taking warfarin.
The agency warned that patients with artificial heart valves should not take the drug because it was not studied in that population.
In after-hours trading Bristol-Myers rose 60 cents to $32.50. Pfizer picked up 13 cents at $25.02.