FDA approves BioCryst's ORLADEYO 150 mg oral pellet formulation for prophylactic HAE therapy

The FDA approved BioCryst Pharma's supplemental new drug application for the 150 mg oral pellet formulation of once-daily ORLADEYO (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

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Food and Drug AdministrationBioCryst Pharmaceuticals, Inc.

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