FDA Approves Generic Version of Edema Rx

Qualitest Pharmaceuticals March 24 announced that the Food and Drug Administration has approved its generic version of Roche’s Demadex (toresmide) 5 mg, 10 mg, 20 mg, and 100 mg tablets.

Demadex is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease, and for the treatment of hypertension alone or in combination with other antihypertensive agents, the Huntsville, Ala.-based company said.

Roche withdrew Demadex from the market. However, in 2009, FDA determined that the drug was not withdrawn from sale for reasons of safety or effectiveness and the agency would continue to approve generic ...