The US subsidiary of Glenmark Generics today said that they have been granted final abbreviated new drug application (ANDA) approval by the United States Food and Drug Administration (USFDA) for Lithium Carbonate 300 mg extended-release tablets. The company said that it will commence the marketing and distribution of the product immediately.
Lithium Carbonate 300 mg extended-release tablets are Glenmark's generic version of Lithobid by Noven Therapeutics which is indicated for manic episodes of bipolar disorder. According to IMS Health, the drug had total sales of $21 million for 12 months ending September. Glenmark will be one of the two generic players of this drug in the market.
Glenmark is currently authorised to distribute 66 products in the United States. The company said that it will maintain an aggressive ANDA filing strategy and will also explore partnerships to augment its portfolio.
