Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration ("FDA") approval for the generic version of KlorCon® extended-release tablets (600 mg and 750 mg), manufactured by Upsher-Smith Laboratories, Inc., and marketed by Sandoz Pharmaceuticals, Inc. The FDA concluded that Perrigo's product is therapeutically equivalent to KlorCon® extended-release tablets and can be substituted with the full expectation that it will produce the same clinical effect and safety profile as KlorCon® extended-release tablets when used under the conditions specified in the label.
KlorCon® extended-release tablets (potassium chloride) are indicated for the treatment and prevention of low levels of potassium in the bloodstream (hypokalemia). Combined generic and branded sales for the twelve months ending September 2015 were $81 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This product approval, and launch in the next several weeks, demonstrates the growing strength of our Rx portfolio. The Rx team continues to gain important approvals in difficult product formulations. These approvals strengthen the Perrigo mission of providing Quality Affordable Healthcare Products® to our customers around the world."
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