Lannett Company has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq, the therapeutic equivalent to the reference listed drug of Actavis Labs FL, Inc., and Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Temodar® Capsules of Merck & Co. According to IMS, total U.S. sales in 2015 of Potassium Chloride Extended-release Capsules USP, 8 mEq and 10 mEq and Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg at Average Wholesale Price (AWP) were approximately $89 million and $206 million, respectively.
"The Potassium Chloride product represents the second approval received from our acquisition of Kremers Urban (KU)," saidArthur Bedrosian, chief executive officer of Lannett. "This is our second approval for Temozolomide, a product for which our KU subsidiary also recently received FDA approval and the only drug candidate in the pipelines of both Lannett and KU. We expect to launch Temozolomide within the next few months and are evaluating launch options for our Potassium Chloride product."