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FDAnews Drug Daily Bulletin
March 10, 2011 | Vol. 8 No. 49
Advisory Committee Recommends Lower Dose of Novartis’ Indacaterol
An FDA advisory committee agreed to recommend approval of a lower dose of Novartis’ chronic obstructive pulmonary disease drug indacaterol after finding that a high dosage version didn’t provide any additional benefit. Ultimately, members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee Tuesday were not satisfied with the drug’s long-term safety and clinical benefits at the 150 mcg dose and rejected approval for that strength. However, the panel voted 13-4 to approve the 75 mcg dose and 12-5 to reject the 150 mcg dose.
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