Barr Laboratories Inc has received approval from the U.S. Food & Drug Administration for Ethambutol Hydrochloride Tablets 400 mg, USP, the generic equivalent of Dura Pharmaceuticals Inc's Myambutol tablets. Barr's Ethambutol will be the only generically available product.
"The Company is pleased to add Ethambutol to our portfolio of antibacterial products and plans to launch the product immediately," said Bruce L. Downey, Barr's Chairman and CEO.
Myambutol is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculosis drug, but should be used in conjunction with at least one other antituberculosis drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies. Current annual sales are approximately $17.8 million.