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FDA Declines MannKind – United Therapeutics' Formulated Treprostinil For Lung Disease

  • The FDA has issued a complete response to United Therapeutics Corporation (NASDAQ: UTHR) regarding the marketing application for Tyvaso DPI for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • The FDA’s letter noted only a single deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the treprostinil drug substance.
  • In addition, the FDA did not cite any deficiencies or issues related to operations performed at the MannKind Corporation’s (NASDAQ: MNKD) facility for the manufacture, testing, and packaging of finished Tyvaso DPI including its associated device.
  • “We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier,” said Martine Rothblatt, Chairperson and CEO of United Therapeutics.
  • Related content: Benzinga’s Full FDA Calendar.
  • Price Action: MNKD shares are down 16.7% at $4.24, UTHR stock is down 1.16% at $184.9 during the premarket session on Monday’s last check.

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