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First and only oral liquid dosage form of potassium-sparing diuretic spironolactone approved by FDA
October 30, 2017
By: Kristin Brooks
Managing Editor, Contract Pharma
CMP Pharma’s CaroSpir, the first FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone, is now available. CaroSpir was approved on August 4. CaroSpir oral suspension is for adult patients who have difficulty swallowing, or who cannot swallow tablets. It provides a stable and consistent dose of spironolactone. Previously, patients that required a liquid form of spironolactone have had to rely on unapproved pharmacy compounded formulations, which typically have limited shelf life, are not quality control tested for potency and sterility/bioburden. “CaroSpir is intended for a subset of the patient population that needs spironolactone, but has difficulty swallowing or inability to swallow. Until today there was no FDA-approved oral suspension of spironolactone to satisfy this unmet need. The availability of CaroSpir now gives healthcare providers and appropriate patients a convenient, safe and approved liquid option,” said Gerald Sakowski, chief executive officer of CMP Pharma, Inc.
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