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The approval covers 3.125 milligram, 6.25 milligram, 12.5 milligram and 25 milligram strength tablets of carvedilol, the active ingredient in Coreg. Tentative approval means that the company's marketing application is in order but that litigation or patent issues need to be resolved first before the approval becomes final.
Coreg had U.S. sales of about $1.14 billion in 2005. Beta-blockers are drugs that lower hormones that increase blood pressure.