FDA approves Mylan ANDA for Lithium Carbonate Extended-release tablets

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.