Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicine This week, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age…
Changes in voice and breath are significantly correlated with changes in symptoms scores for chronic obstructive pulmonary disease (COPD), with voice signatures detectable even before the symptoms are present. This was among the findings of research presented at the CHEST 2021 Annual Meeting, held live in Orlando, FL, and virtually, October 17 to 20. Study…
Rules Provide Additional Information on the Requirements for Future Premarket Tobacco Product Applications and Substantial Equivalence Reports On October 4, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of Premarket Tobacco Product…
Circassia announced that the U.S. Food and Drug Administration (FDA) approved its medication Duaklir for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The company plans to launch the therapy in the United States in the second half of 2019. Duaklir is a combination of two long-acting bronchodilators: aclidinium bromide (400 mcg) and formoterol fumarate (12 mcg). It…
The FDA has launched strong regulatory and enforcement moves against the industry, branding the use of e-cigarettes among teens and ‘epidemic.’ In a pronouncement, Food and Drug Administration Commissioner Scott Gottlieb on Sept. 12 declared e-cigarette use “epidemic” among teens, signaled a possible ban on flavored e-cigarette liquids and launched sweeping enforcement efforts against retailers…