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AstraZeneca heartburn drug wins new approval

The FDA has approved a new formulation for AstraZeneca's prescription drug Nexium, used in the treatment of heartburn and gastric conditions.

The new Nexium formulation is an oral suspension product and will be an alternative to Nexium tablets. This new oral suspension version of Nexium contains esomeprazole, the same active ingredient used in the original capsules. The esomeprazole granules used in this formulation are mixed with water to form a suspension and are given by oral or gastric administration.

“Some patients with acid-related diseases have difficulties swallowing their oral medication when it is a solid pill,” said Doug Levine, executive director for Nexium. “This new prescription option to swallow an oral suspension of Nexium or to have it administered via a stomach tube provides these patients with an alternative method of administration that they can take instead of the Nexium capsule.”

The new formulation of Nexium will be available in the first quarter of 2007.

Nexium is approved for treating heartburn and other symptoms associated with acid reflux disease. Nexium is also indicated for reducing the risk of stomach ulcers developing among at risk patients on anti-inflammatory drug therapy.