FDA approves Seebri Neohaler (glycopyrrolate) for chronic obstructive pulmonary disease- Novartis
The FDA has approved Seebri Neohaler (glycopyrrolate) inhalation powder 15.6 µg, from Novartis, as monotherapy for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Novartis expects that Seebri Neohaler will be available in the first quarter of 2016. Utibron (indacaterol/glycopyrrolate combination) and Seebri (glycopyrrolate alone) are delivered via the low-resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.
Seebri Neohaler, previously known as NVA 237, is a twice-daily long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Comment: Utibron is known as Ultibro in the EU and some other markets.
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