On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal ...
This system doesn’t apply to albuterol (rescue) inhalers, since most people don’t use this medication on any regular basis. Instead, These medications are used when an asthma attack is occurring. If ...
Teva holds an approved NDA for its ProAir® HFA Inhalation Aerosol product, which permits Teva to market and sell an inhaler device that administers the API albuterol sulfate. Teva listed several ...
Leak Rate. It is common for MDIs to lose propellant during storage. The propellant-leak rate of the test MDIs was compared with that of the controls (Figure 3). The leak rates for the Proventil ...
A New Jersey district court correctly ruled that the patents, which cover the device’s components, were improperly listed in the FDA’s Orange Book because they don’t claim the drug’s active ingredient ...
stock and administer albuterol sulfate to any child experiencing respiratory distress. "The proposed research represents a significant opportunity to empower policymakers, health care providers ...
After exposure to extreme environmental temperatures, an increase in propellant-leak rate was observed with Proventil HFA and Ventolin HFA MDIs, but little to no change was found in particle size ...