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Shire plc, the global specialty biopharmaceutical company, announced that it has received approval from the US Food and Drug Administration for INTUNIV™ Extended Release Tablets for the treatment of Attention–Deficit/Hyperactivity Disorder in children and adolescents aged 6 to 17 years. INTUNIV, a once–daily formulation of guanfacine, is the first selective alpha–2A adrenergic receptor agonist approved for the treatment of ADHD.
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Novartis receives approval in the European Union for Onbrez Breezhaler, a new once-daily bronchodilator for patients with COPD
Novartis, 12/04/09
Safety concerns slow new drug review and approval processes
Formulary , 12/02/09
Teva Announces The Submission Of A Biologics License Application (BLA) For XM02 For The Treatment Of Chemotherapy-Induced Neutropenia
Teva Pharmaceutical Industries, 12/02/09
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