The FDA has approved a supplemental NDA (new drug application) submitted by Otsuka Pharmaceutical and Bristol-Myers Squibb for Abilify (aripiprazole) to treat manic and mixed episodes related to bipolar I disorder in children between 10 and 17 years of age. The drug already has approval for the treatment of manic and mixed episodes related to Bipolar I Disorder with or without psychotic features in adults.

The Food and Drug Administration has approved use of the drug Nexium in children aged 1 to 11 who have acid reflux disease.FDA said Thursday it approved liquid and delayed-release capsules of Nexium in doses of 10 milligrams or 20 milligrams for these youngsters. Nexium, manufactured by AstraZeneca is a proton pump inhibitor, which reduces the amount of acid produced in the stomach and helps heal damage to the esophagus caused by excess acid.

The approval was for short-term use in these children, FDA said. The most common side effects in children were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness, the agency said.

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