PITTSBURGH, Aug. 10, 2012 -- Mylan Inc. (Nasdaq: MYL) 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.
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.
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