Date: 2012-03-20
Type of information:
Product name: Arcapta Neohaler®/Onbrez Breezhaler®
Compound: indacaterol (QBAB149)
Therapeutic area:
Action mechanism: long-acting beta2-agonist (LABA) class
Company: Novartis (Switzerland)
Disease: once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Latest news: In the US, Novartis is seeking approval for the use of QAB149 as a once-daily long-term maintenance bronchodilator treatment for airflow obstruction in patients with COPD, including bronchitis and/or emphysema. Novartis is not seeking an indication for asthma. If approved in the US, the proposed brand name will be Arcapta™ Neohaler™.
* On March 23, 2011, Novartis announced that FDA has extended the regulatory review period for QAB149 (indacaterol) for the once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The FDA asked for a three-month extension in order to complete its review of the new drug application (NDA) for QAB149 by July 2011. In its notification, the FDA said it needed more time to examine the data submitted by Novartis in support of the application. The agency did not request additional data.
* On March 19, 2012, Novartis announced that once-daily Arcapta™ Neohaler™ (indacaterol inhalation powder) 75 mcg is now available in the US and in pharmacies nationwide.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-07-01
UE authorization: 2009-11-30
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
