Subject: FDA
AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF KONVOMEPtm (omeprazole and sodium bicarbonate for oral suspension)
WOBURN, Mass., Sept. 2, 2022 /PRNewswire/ -- Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose-forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Konvomeptm (omeprazole and sodium bicarbonate for oral suspension). Konvomeptm is approved for the treatment of active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill patients.
"We are very pleased that patients will soon have access to this FDA-approved oral liquid formulation option of a commonly prescribed proton pump inhibitor1," said Richard Blackburn, CEO of Azurity Pharmaceuticals. "Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Konvomeptm may give patients, particularly patients with difficulty swallowing pills or capsules, an option for treatment tailored to their needs."
"Patients who struggle with taking solid oral dosage forms may be overlooked and have historically had limited FDA-approved treatment options available as liquid formulations," said Olga Hilas, PharmD, MPH, BCPS, BCGP, Professor, Clinical Health Professions, St. John's University College of Pharmacy & Health Sciences, Queens, New York.
It is expected that Konvomeptm will become commercially available in pharmacies nationwide in Q1 2023. For full prescribing and additional information, please go to www.konvomep.com.
Azurity Pharmaceuticals is a privately held pharmaceutical company that focuses on innovative products that meet the specific needs of overlooked patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
1NSP, PPI units June 2018 ? June 2022
SOURCE Azurity Pharmaceuticals, Inc.
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