FDA Approves OTC Nexium 24HR Caps
The FDA has approved over-the-counter (OTC) Nexium 24HR (esomeprazole; Pfizer Consumer Healthcare) for patients suffering from frequent heartburn. Pfizer acquired exclusive rights from AstraZeneca to market non-prescription Nexium.
Prescription esomeprazole is a proton pump inhibitor currently indicated for triple therapy (w. amoxicillin + clarithromycin) for H. pylori eradication in duodenal ulcer disease; short-term treatment and maintenance of healing of erosive esophagitis (EE), symptomatic GERD; short-term treatment of EE due to acid-mediated GERD in infants 1month to <1year; to reduce risk of NSAID-associated gastric ulcer; and for long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).
OTC Nexium 24HR will be available in 20mg delayed-release capsules.For more information call (800) 879-3477 or visit Pfizer.com.