United Therapeutics Announces FDA Approval of Tyvaso DPI

Date: Wed, 25 May 2022 03:05:35 GMT
By: Drugs.com New Drug Approvals
Source: Drugs.com New Drug Approvals
Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI are the only therapies approved by the FDA to treat PH-ILD.FDA approval of the new drug application for Tyvaso DPI is supported by data from BREEZE, an open label study of 51 PAH patients on a stable regimen of Tyvaso Inhalation Solution who were transitioned to Tyvaso DPI.

About TYVASO® (treprostinil) Inhalation Solution and TYVASO DPI™ (treprostinil) Inhalation PowderEyebrow (abbreviated) IndicationFor the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.

Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm.

Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.

TYVASOHCP.

com or call 1‑877‑UNITHER (1-877-864-8437).

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Source:Drugs.com New Drug Approvals

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