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Arcapta FDA Approval History

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

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

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).

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Development timeline for Arcapta

DateArticle
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

See also

Arcapta (indacaterol) Consumer information

Further information

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