The FDA has informed Novartis that it needs a three-month extension for its review of data supporting the company’s NDA for QAB149 (indacaterol). The new completion date for the review would be July 2011.
The agency’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of approving a 75 mcg dose of the drug but against approval of a 150 mcg dose.
The QAB149 DPI for the treatment of COPD, which is called Onbrez Breezhaler in the countries where it is marketed currently, will be called the Arcapta Neohaler in the US.
Read the company’s press release.
