FDA Extends Indacaterol Review

FDA Extends Indacaterol Review
Drug Discovery & Development - March 24, 2011

NEW YORK (AP) - The Food and Drug Administration is extending a review of a lung disease drug made by Novartis AG, the Swiss drugmaker said Wednesday.
Novartis said the FDA now expects to complete its review in July instead of April. It said the FDA needs more time to review data from clinical trials, but has not asked for any new information. The agency is reviewing Novartis' application on a drug candidate called QAB149, or indacaterol, which is a once-per-day treatment for patients with chronic lung conditions like bronchitis or emphysema.
Indacaterol is a bronchodilator, or a drug that opens up airway passages in the lungs to ease breathing.
In February, an FDA advisory panel recommended the drug be approved. Novartis is seeking approval to market the drug in strengths of 75 micrograms and 150 micrograms per day. The company said the drug is approved under the name Onbrez Breezhaler in more than 50 countries. Onbrez Breezhaler is marketed in strengths of 150 micrograms and 300 micrograms per day.
Date: March 23, 2011
Source: Associated Press