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Arcapta Approval History

  • FDA approved: Yes (First approved July 1st, 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 History and FDA Approval Process 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

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