Liquidia Corp

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Liquidia Announces FDA Acceptance Of New Drug Application Resubmission For Liq861 (Treprostinil) Inhalation Powder

Published: 06/02/2021 11:48 GMT
Liquidia Corp (LQDA) - Liquidia Announces FDA Acceptance of New Drug Application Resubmission for Liq861 (treprostinil) Inhalation Powder.
Liquidia Corp - FDA Confirmed That Resubmission Was a Complete, Class 2 Response to Previous Action Letter Issued on November 24, 2020.
Liquidia Corp - FDA Set a PDUFA Goal Date of November 7, 2021.
Liquidia - Any Final FDA Approval of NDA for Liq861 Would Be Subject to Resolution of Pending Hatch-waxman Litigation Commenced by United Therapeutics.
Liquidia Corp - New Drug Product May Not Be Marketed Until Date of Final Approval Which is Confirmed by FDA at Time of Final Submission.