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Arcapta FDA Approval History

Last updated by Judith Stewart, BPharm on May 4, 2021.

FDA Approved: Yes (Discontinued) (First approved July 1, 2011)
Brand name: Arcapta
Generic name: indacaterol
Dosage form: Neohaler
Previous Name: QAB149
Company: Novartis Pharmaceuticals Corp.
Treatment for: COPD

Arcapta (indacaterol inhalation powder) is a long-acting beta2-agonist (LABA) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Development timeline for Arcapta

Jul  1, 2011Approval FDA Approves Arcapta Neohaler to treat Chronic Obstructive Pulmonary Disease
Mar  9, 2011FDA Advisory Committee Recommends US Approval of Novartis Once-Daily Bronchodilator QAB149 for COPD
Oct 23, 2009Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD

Further information

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