Par announced it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release (ER) Capsules.
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).
Potassium Chloride ER Capsules are available in 600mg (8mEq K) and 750mg (10mEq K) strengths. Par has begun shipping this product.
For more information call (800) 828-9393 or visit ParPharm.com.