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FDA approves Utibron and Seebri Neohaler DPIs

Novartis has announced FDA approval for the Seebri Neohaler glycopyrrolate DPI and the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD. According to the company, both inhalers should be available in the first quarter of 2016. The company’s indacaterol monotherapy DPI, marketed in the US as Arcapta Neohaler, was approved by the FDA in 2011.

In Europe, the indacaterol/glycopyrrolate DPI is marketed as Ultibro Breezhaler and the glycopyrrolate DPI as Seebri Breezhaler. The indacaterol DPI is marketed in Europe as Onbrez Breezhaler.

President of Novartis Corporation and Novartis Pharmaceuticals Corporation, and US Company Head Christi Shaw said, “Patients have told us about the tremendous impact their COPD can have on everyday activities. With this approval, the COPD community now has a new medicine that can help so many patients by improving not only their symptoms, but also their health-related quality of life. This means the possibility of doing things that matter to them.”

Read the Novartis press release.

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published on October 29, 2015

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