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Home » FDA APPROVES ASTRAZENECA'S LIQUID NEXIUM
FDA APPROVES ASTRAZENECA'S LIQUID NEXIUM
October 25, 2006
A new liquid formulation of AstraZeneca's prescription proton pump inhibitor Nexium (esomeprazole magnesium) has been approved by the FDA. Nexium for Delayed-Release Oral Suspension is now approved for the treatment of gastroesophageal reflux disease (GERD), including symptomatic GERD, and healing and maintenance of healing of erosive esophagitis.
Each packet of Nexium for Delayed-Release Oral Suspension contains either 20 mg or 40 mg of esomeprazole, the same active ingredient used in Nexium Delayed-Release Capsules. The esomeprazole granules and inactive granules used in this formulation are mixed with water to form a suspension and are given by oral, nasogastric or gastric administration. The new formulation will be available in the first quarter of 2007.
Nexium is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. The drug is also indicated for for the treatment of Zollinger-Ellison Syndrome and for reducing the risk of gastric ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of stomach ulcers.
KEYWORDS Drug Pipeline Alert
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