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), ...

which permits Teva to market and sell an inhaler device that administers the API albuterol sulfate. Teva listed several patents in the OB for ProAir® HFA, including several claiming components of ...

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 ...