Mylan Launches Lithium Carbonate Extended-Release Tablets USP

Mylan Inc.

today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its 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.(1) Lithium Carbonate Extended-release Tablets USP, 450 mg, had U.S. 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.