FDA News

FDA approves third-generation nebulizer for inhalation system

The FDA approved a new inhalation device for use with a treprostinil inhalation system for the treatment of pulmonary arterial hypertension, according to a press release from United Therapeutics.

Treprostinil (Tyvaso) was approved in 2009 and the inhalation system consists of the drug product, an ultrasonic nebulizer and accessories. The Tyvaso system is the most prescribed inhalation therapy for PAH in the U.S., according to the release.

The new nebulizer, TD-300/A, is more ergonomic with a single button operation, an intuitive user face and an internal, rechargeable battery, the company stated in the release.

“Tyvaso is an important element of our continuum of care, which provides a range of treprostinil therapy options across a spectrum of PAH patients,” Michael Benkowitz, president and chief operating officer of United Therapeutics, said in the release. “The launch of the TD-300/A, planned for mid-2018, will further optimize Tyvaso therapy for patients and, we believe, reduce the rate of therapy discontinuation associated with the current nebulizer.”

Disclosure: Benkowitz is an employee of United Therapeutics.

The FDA approved a new inhalation device for use with a treprostinil inhalation system for the treatment of pulmonary arterial hypertension, according to a press release from United Therapeutics.

Treprostinil (Tyvaso) was approved in 2009 and the inhalation system consists of the drug product, an ultrasonic nebulizer and accessories. The Tyvaso system is the most prescribed inhalation therapy for PAH in the U.S., according to the release.

The new nebulizer, TD-300/A, is more ergonomic with a single button operation, an intuitive user face and an internal, rechargeable battery, the company stated in the release.

“Tyvaso is an important element of our continuum of care, which provides a range of treprostinil therapy options across a spectrum of PAH patients,” Michael Benkowitz, president and chief operating officer of United Therapeutics, said in the release. “The launch of the TD-300/A, planned for mid-2018, will further optimize Tyvaso therapy for patients and, we believe, reduce the rate of therapy discontinuation associated with the current nebulizer.”

Disclosure: Benkowitz is an employee of United Therapeutics.