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News From the Food and Drug Administration
December 18, 2018

A First in COPD Treatment

JAMA. 2018;320(23):2413. doi:10.1001/jama.2018.19375

The first once-daily nebulized bronchodilator has received FDA approval as maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).

Revefenacin, a long-acting muscarinic antagonist, is expected to be available by the end of this year. It will be marketed as Yupelri. The drug should not be used as rescue therapy for acute bronchospasm episodes or during acute exacerbations. Revefenacin was developed by Mylan and Theravance Pharmaceuticals Inc, which conducted market research showing that about 9% of US patients with COPD use a nebulizer for ongoing maintenance therapy.

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