Mylan Pharmaceuticals has received final FDA approval for its abbreviated new drug application (ANDA) for Lithium Carbonate Extended-release tablets USP, 300mg.
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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.