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Home Industry News Novartis granted EU approval for distribution of Onbrez Breezehaler

Novartis granted EU approval for distribution of Onbrez Breezehaler

3rd December 2009

Novartis has announced that the European commission (EC) has approved Onbrez Breezhaler (QAB149 or indacaterol) – its once-daily maintenance bronchodilator – for distribution in the EU.

Indicated for the treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD), the product has been approved in both 150 mcg and 300 mcg doses.

A trial of the treatment saw it demonstrate superiority to tiotropium, formoterol and salmeterol.

It has been cleared for marketing and the treatment is the first new inhaled compound for EU COPD patients within the last seven years.

Joe Jimenez, chief executive officer of the Novartis Pharmaceuticals Division, stated: “This new and effective therapy will soon be available to people in the EU with COPD and, through better symptom control, will help them to live more active and productive lives.”

In other Novartis news, the firm revealed last week that it has received the rights to INCB18424 and INCB28060 – two oral targeted investigational therapies intended for use in patients with life-threatening blood disorders and cancers.

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