Briefing materials prepared by the FDA for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting scheduled for March 8, 2011 ask committee members to consider the safety of the higher dose of Novartis’s indacaterol inhalation powder. The FDA had already issued a complete response letter in October 2009, in which it asked Novartis to consider lower doses. The company then reduced the proposed doses to 75 mcg and 150 mcg from 150 mcg and 300 mcg.
The memorandum prepared by Badrul Chowdhury, Director of the Division of Pulmonary, Allergy, and Rheumatology Products states that discussion points for the committee meeting will include “whether the proposed doses of 75 mcg and 150 mcg and the once-daily dosing frequency are supported by submitted data” and “whether the second higher dose of 150 mcg is necessary and supported by submitted efficacy data and balancing safety data.”
Read the briefing document.
