The U.S. FDA has granted final approval of CMP Pharma’s new drug application (NDA) for CaroSpir (spironolactone) oral suspension, 25 mg/5mL. The approval marks the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone.
 
“CaroSpir provides a stable, ready to use and consistent liquid treatment option for adult patients, including those who have difficulty swallowing, or who cannot swallow tablets,” said Gerald Sakowski, chief executive officer, CMP Pharma. “Up until now, these patients have been prescribed a pharmacy compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians.”
 
CaroSpir will be introduced early in the fourth quarter of 2017. For more information visit CaroSpir.com.

Spironolactone oral suspension is the only FDA-approved oral liquid dosage form of its kind