United said on Monday the health regulator's draft label for the
drug, Tyvaso DPI, includes its use as a treatment for pulmonary
arterial hypertension (PAH), as well as PAH associated with
interstitial lung disease (PH-ILD).
In its complete response letter, the agency did not cite any
deficiencies related to operations at MannKind's device
manufacturing and testing facility for Tyvaso DPI. [Pn2cP6yja]
Shares of Mannkind were down 17.9% at $4.18 in premarket trading.
![](http://archives.lincolndailynews.com/2021/Oct/18/images/ads/current/safety-tip-daily-5.png)
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![](http://archives.lincolndailynews.com/2021/Oct/18/images/ads/current/farmersbank_lda_PPP_2019.png) While PAH is a type of high
blood pressure that affects blood vessels in the
lungs, PH-ILDs are a group of diseases that
cause inflammation and scarring of the lung
tissue, making it harder to breathe.
(Reporting by Manas Mishra and Bhanvi Satija in
Bengaluru; Editing by Ramakrishnan M.)
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