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Utibron Neohaler Approval History

  • FDA approved: Yes (First approved October 29th, 2015)
  • Brand name: Utibron Neohaler
  • Generic name: glycopyrrolate and indacaterol
  • Dosage form: Inhalation Powder
  • Company: Novartis Pharmaceuticals Corporation
  • Treatment for: COPD

Utibron Neohaler (glycopyrrolate and indacaterol) is a long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) fixed-dose combination for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Development History and FDA Approval Process for Utibron Neohaler

Oct 29, 2015Approval FDA Approves Utibron Neohaler (indacaterol/glycopyrrolate) for COPD

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