FDA approval of Ammonul for urea cycle disorder

On February 18, 2005, the U.S. Food and Drug Administration (FDA) granted orphan drug status to Ammonul (combination of sodium phenylacetate and sodium benzoate) as a therapy for the treatment of high levels of ammonia in the blood and associated encephalopathy in patients with metabolic disorders known as urea cycle disorders. Ammonul is given intravenously in the hospital as a rescue medication when an individual with a urea cycle disorder is in metabolic crisis. The medication pulls the toxic ammonia out of the bloodstream. Medicis, the maker of Ammonul, also makes Buphenyl, a daily maintenance medication for urea cycle disorders.