FDA actions in pulmonology from 2022 you may have missed
Click Here to Manage Email Alerts
Healio Pulmonology has compiled the top news from the FDA posted in 2022.
Top FDA pulmonology stories from this year include the FDA panel’s committee meeting to improve pulse oximeter accuracy among patients with darker skin pigmentation and the FDA’s marketing denial orders to Juul Labs for their vaping products.
Read these and more of the most-read FDA pulmonology stories of 2022 below.
FDA panel: Pulse oximeters show clear ‘disparate performance’ for darker skin pigmentation
At a Medical Devices Advisory Committee meeting held Nov. 1, panelists recommended improvements to the FDA regarding pulse oximeters and their accuracy among patients with darker skin pigmentation. Read more.
FDA denies authorization to market Juul vaping products
The agency issued marketing denial orders to Juul Labs for all of their vaping devices and related products in June. As a result, the company must stop selling and distributing these products, and those currently on the U.S. market must be removed. Read more.
FDA approves first generic of Symbicort for asthma, COPD
The FDA announced approval of the first generic of Symbicort — budesonide and formoterol fumarate dihydrate — Inhalation Aerosol for the treatment of asthma and COPD, according to an agency press release. Read more.
Inhaled therapy receives FDA breakthrough designation for non-cystic fibrosis bronchiectasis
The FDA granted breakthrough therapy designation to colistimethate sodium powder for nebulization solution (CMS I-neb, Zambon) to reduce pulmonary exacerbations in adults with non-cystic fibrosis bronchiectasis and Pseudomonas aeruginosa. Read more.
FDA declines approval of gefapixant for chronic cough
The agency issued a complete response letter declining to approve a new drug application for gefapixant to treat adults with refractory and unexplained chronic cough, according to a press release from Merck. Read more.
FDA approves nitric oxide generator to treat neonates with hypoxic respiratory failure
Beyond Air received approval for its nitric oxide generator and delivery system to treat term and near-term neonates with hypoxic respiratory failure, according to a company press release. Read more.
FDA proposes rules prohibiting menthol cigarettes, flavored cigars
In April, the FDA proposed prohibiting menthol cigarettes and flavored cigars. The new product standards are designed to substantially prevent disease and death from combusted product use and to prevent young people from starting to smoke. Read more.
FDA panel votes against sabizabulin EUA for COVID-19 at risk for ARDS
The Pulmonary-Allergy Drug Advisory Committee voted 8-5, leaning against granting sabizabulin (VERU-111, Veru Inc.) emergency use authorization to treat patients hospitalized with COVID-19 and at risk for acute respiratory distress syndrome. Read more.
FDA expands approval of Orkambi for young children with cystic fibrosis
Lumacaftor and ivacaftor (Orkambi, Vertex Pharmaceuticals) received expanded approval to include the treatment of children with cystic fibrosis aged 1 year to younger than 2 years, according to a manufacturer-issued press release. Read more.
FDA approves inhaled treprostinil for treatment of PAH, pulmonary hypertension-ILD
United Therapeutics Corp. announced that the FDA approved the Tyvaso dry powder inhaler for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability. Read more.