Mylan Inc. announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith’s Klor-Con. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. Mylan has begun shipping this product.
Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), had U.S. sales of approximately $135.05 million for the 12 months ending June 30, 2014, according to IMS Health.
Currently, Mylan has 294 ANDAs pending FDA approval representing $105.7 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.
Date: August 22, 2014