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Utibron Neohaler FDA Approval History

Last updated by Judith Stewart, BPharm on May 3, 2020.

FDA Approved: Yes (Discontinued) (First approved October 29, 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 timeline for Utibron Neohaler

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

Further information

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