Mylan Launches Generic Version of Lithobid Tablets

Mylan Inc.

today announced that its subsidiary Mylan Pharmaceuticals Inc. 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, 300 mg. This product is 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.(1) Lithium Carbonate Extended-release Tablets USP, 300 mg, had U.S. sales of approximately $21 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping this product immediately. Currently, Mylan has 167 ANDAs pending FDA approval representing $83.8 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $25.6 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.