Chain Drug Review - Nexium wins O.K. for use by children
WILMINGTON, Del. — The Food and Drug Administration has approved the use of Nexium (esomeprazole magnesium) in children ages 1 to 11 for the short-term treatment (up to 8 weeks) of gastroesophageal reflux disease (GERD), helping to address what manufacturer AstraZeneca PLC asserts is an important unmet need for pediatric patients.
Nexium received approval in April 2006 for patients 12 to 17 years old for treating GERD. sildenafil. a condition in which the contents of the stomach back up into the esophagus. Symptoms of GERD often include heartburn, regurgitation and upset stomach.
The FDA has also approved a new 10-mg dose formulation of Nexium for delayed-release oral suspension for use in children ages 1 to 11.
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This 10-mg dose formulation is in addition to the 20-mg and 40-mg suspensions that were approved in October 2006 for use in adolescent patients 12 to 17 years old (as well as adults).
“This dosing alternative of Nexium for oral suspension allows such patients as children and the elderly who are unable to swallow capsules or tablets to have an alternative treatment option for controlling their GERD,” says brand medical director Marta Illueca.
“The FDA approvals build upon AstraZeneca’s commitment to better understanding the many patient populations affected by GERD.”
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