WOODCLIFF LAKE, N.J., April 7, 2014 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for potassium chloride extended-release (ER) capsules, USP, in 600 mg (8 mEq K) and 750 mg (10 mEq K) strengths. Potassium chloride ER is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, in patients with hypokalemic familial periodic paralysis, and for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop (digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states).
Par has begun shipping all approved strengths of the product. According to IMS Health data, annual U.S. sales of potassium chloride ER capsules are approximately $142 million.
Important Information About Potassium Chloride ER Capsules
Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Controlled release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological or pharmacological cause for arrest or delay in capsule passage through the gastrointestinal tract.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies