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 ...

Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler, ...

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA), ...

This will remind you to get a new inhaler on October 31, even if the old inhaler continues to spray propellant. This system doesn’t apply to albuterol (rescue) inhalers, since most people don’t use ...

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 ...

Amneal beats Teva’s challenge of ruling on some ProAir patents Decision could impact other ‘junk device listings,’ FTC says Five patents related to Teva Pharmaceutical Industries Ltd.’s ProAir HFA ...

Teva alleged that the patents cover aspects of Teva’s ProAir ® HFA (albuterol sulfate) Inhalation Aerosol. Amneal filed an ANDA application, including a Paragraph IV certification, asserting ...

that could be applied in Arizona and the other 21 states that have stock inhaler laws allowing schools to procure, stock and administer albuterol sulfate to any child experiencing respiratory ...

that could be applied in Arizona and the other 21 states that have stock inhaler laws allowing schools to procure, stock and administer albuterol sulfate to any child experiencing respiratory ...

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 ...