According to the FDA, three DPIs marketed by Sunovion in the US have been discontinued as of March 10, 2020. Sunovion acquired the US rights to Utibron (indacaterol/glycopyrrolate) Neohaler, Seebri (glycopyrrolate) Neohaler, and Arcapta (indacaterol) Neohaler from Novartis in December 2016. The inhalers are marketed elsewhere as Ultibro Breezhaler, Seebri Breezhaler, and Onbrez Breezhaler.
Arcapta Neohaler was approved by the FDA in 2011 and was launched by Novartis in 2012. Utibron and Seebri Neohalers were approved by the FDA in October 2015; Sunovion launched Utibron in April 2017 and Seebri in October 2017.
Neither Sunovion nor Novartis responded to requests for comment. Sunovion’s US web site currently lists the three inhalers among its marketed products.
UPDATE: Sunovion has now provided the following statement: “Sunovion remains committed to people living with chronic obstructive pulmonary disease (COPD), and the Company has made a strategic decision to focus its respiratory business on its core products Brovana (arformoterol tartrate) Inhalation Solution and Lonhala Magnair (glycopyrrolate) Inhalation Solution. Arcapta Neohaler, Utibron Neohaler and Seebri Neohaler, which were in-licensed by Sunovion from Novartis in December 2016, will no longer be available in the United States effective April 1, 2020.”
View the FDA drug shortage report for Utibron Neohaler.
View the FDA drug shortage report for Seebri Neohaler.
View the FDA drug shortage report for Arcapta Neohaler.
