New Delhi: Glenmark Pharmaceuticals today said it has received approval from the US health regulator to market and distribute generic Lithium Carbonate tablets, used for the treatment of manic depression, in the American market.
The United States Food and Drug Administration (USFDA) has granted approval to the final Abbreviated New Drug Application (ANDA) filed by Glenmark Generics Inc — the company’s US subsidiary — for 300-mg Lithium Carbonate extended release tablets, Glenmark Pharmaceuticals said in a statement.
Glenmark’s Lithium Carbonate extended release tablets are a generic version of Noven Therapeutics’ Lithobid drug, the company said in a filing to the Bombay Stock Exchange (BSE).
Glenmark further added that according to IMS health, total sales of the drug in the American market for the twelve-month period ending September, 2010, amounted to $21 million.
Lithium Carbonate extended release tablets are used for treating manic episodes of biopolar disorder, in which an individual alternates between states of deep depression and extreme elation.
Glenmark is currently authorised to distribute 66 products in the American market.
Shares of Glenmark were being quoted at Rs355.35 in afternoon trade on the BSE today, up 0.69% from their previous close.