Glenmark Pharmaceuticals Ltd. said its subsidiary Glenmark Generic Inc. USA, has obtained ANDA approval from the US FDA for Lithium Carbonate 150 mg, 300mg and 600 mg capsules.
The Mumbai-based company said it would immediately commence marketing and distribution of these products in the US market.
Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. It is also indicated as a maintenance treatment of individuals with a diagnosis of Bipolar Disorder. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
As per IMS health data, Lithium Carbonate capsules had annual sales of $10 million for the period ending September 2008.