The US Food and Drug Administration (FDA)  has approved Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for lithium carbonate extended-release tablets USP, 450 mg. This product is indicated for the treatment of manic episodes of manic depressive illness.

Lithium carbonate extended-release tablets USP, 450 mg, had US sales of approximately $15.2 million for the 12 months ending June 30, 2012, according to IMS Health. Mylan is launching this product immediately.

Currently, Mylan has 166 ANDAs pending FDA approval representing $78.4 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. The company innovates to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership.