Purpose. Special considerations in the selection of medication inhaler devices for elderly patients with chronic obstructive pulmonary disease (COPD) in the ambulatory care setting are reviewed.

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 ...

[23] The Federal Circuit noted that “the fact that the FDA approved Teva’s ProAir® HFA combination product as a drug does not make the inhaler’s device parts a drug. They are still devices ...