Mylan Pharmaceuticals has received final FDA approval for its abbreviated new drug application (ANDA) for Lithium Carbonate Extended-release tablets USP, 300mg.
Mylan has announced immediate shipment of the generic version of Noven Therapeutic's Lithobid Tablets, which are indicated for the treatment of manic episodes of bipolar disorder and as a maintenance treatment for individuals with a diagnosis of bipolar disorder.
According to IMS Health, Lithium Carbonate Extended-release tablets USP, 300mg had US sales of approximately $21m for the twelve months ending 31 March 2012.
At present, Mylan has 167 ANDAs pending FDA approval representing $83.8 bn in annual sales, according to IMS Health.
Mylan is a global pharmaceutical company offering a portfolio of generic pharmaceuticals and brand medications.
