Liquidia has filed a legal challenge to the U.S. Food and Drug Administration’s decision to grant a three-year exclusivity to United Therapeutics’ inhaled drug used to treat lung disorders, the drugmaker said on Thursday.
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The company has filed a case with the U.S. FDA, alleging that due procedure was not followed in allowing rival Liquidia Corp’s application for a blood pressure drug.
The FDA was expected to make its decision by Wednesday, but it is still reviewing Liquidia’s marketing application for possible approval, although it has not asked for any additional clinical data to support the application.