Barr Laboratories Inc has received approval from the U.S. Food and Drug Administration (FDA) for Lithium Carbonate Extended-release Tablets USP, 450 mg, the generic equivalent of GlaxoSmithKline's Eskalith CR Controlled-release Tablets, 450 mg.
Lithium carbonate is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.
Barr's Lithium Carbonate Tablets will compete in a market that had total combined annual sales of approximately $26.5 million, based on IMS sales data for the twelve months ended June 2003.