Approval for PH-ILD inhalation drug 'Tyvaso' expected soon
By Lee, Hye-Kyung | translator Kang, Shin-Kook
24.06.11 05:29:12
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The MFDS has completed evaluating the safety and effectiveness¡¦Anterogen will distribute Tyvaso in South Korea
¡ãTyvaso Inhalation Solution.
The approval of 'Tyvaso Inhalation Solution 0.6 mg/mL (treprostinil)' in South Korea is expected soon. It is approved in the United States as the treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
According to industry sources on the 11th, the safety and effectiveness evaluation of Anterogen for the approval had been completed. The completion of the safety and efficacy evaluation is followed by the NDA.
United Therapeutics¡¯s Tyvaso is a treatment for patients with PH-ILD, and Anterogen has a domestic license.
In August last year, the Ministry of Food and Drug Safety (MFDS) designate
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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