Pharmaceutical Product Guide » Pediatrics http://www.pharmaceuticalproductguide.com/blog A comprehensive guide to pharmaceutical products for medical professionals Fri, 11 Jun 2010 09:15:33 +0000 http://wordpress.org/?v=2.8.2 en hourly 1 Bristol-Myers’ Abilify To Treat Irritabilty In Pediatric Patients With Autistic Disorder gets FDA Approval http://www.pharmaceuticalproductguide.com/blog/2009/12/04/bristol-myers-abilify-to-treat-irritabilty-in-pediatric-patients-with-autistic-disorder-gets-fda-approval/ http://www.pharmaceuticalproductguide.com/blog/2009/12/04/bristol-myers-abilify-to-treat-irritabilty-in-pediatric-patients-with-autistic-disorder-gets-fda-approval/#comments Fri, 04 Dec 2009 14:50:51 +0000 Kimberly O'Brien http://www.pharmaceuticalproductguide.com/blog/?p=167 Bristol Myers SquibbBristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd. said that FDA has approved the supplemental New Drug Application or sNDA for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients of ages 6 to 17 years. The approval of Abilify for the treatment of irritation in patients with autistic disorder in pediatric patients is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies.

]]> http://www.pharmaceuticalproductguide.com/blog/2009/12/04/bristol-myers-abilify-to-treat-irritabilty-in-pediatric-patients-with-autistic-disorder-gets-fda-approval/feed/ 0 Abilify gets FDA approval for children http://www.pharmaceuticalproductguide.com/blog/2008/03/05/abilify-gets-fda-approval-for-children/ http://www.pharmaceuticalproductguide.com/blog/2008/03/05/abilify-gets-fda-approval-for-children/#comments Wed, 05 Mar 2008 17:49:02 +0000 Kimberly O'Brien http://www.pharmaceuticalproductguide.com/blog/2008/03/05/abilify-gets-fda-approval-for-children/ 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.

]]> http://www.pharmaceuticalproductguide.com/blog/2008/03/05/abilify-gets-fda-approval-for-children/feed/ 0 FDA OKs Nexium in children ages 1 to 11 http://www.pharmaceuticalproductguide.com/blog/2008/02/29/fda-oks-nexium-in-children-ages-1-to-11/ http://www.pharmaceuticalproductguide.com/blog/2008/02/29/fda-oks-nexium-in-children-ages-1-to-11/#comments Fri, 29 Feb 2008 19:07:39 +0000 Melissa Chang http://www.pharmaceuticalproductguide.com/blog/2008/02/29/fda-oks-nexium-in-children-ages-1-to-11/ 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.

Get the full story here.

]]> http://www.pharmaceuticalproductguide.com/blog/2008/02/29/fda-oks-nexium-in-children-ages-1-to-11/feed/ 0