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Home » CDER Denies Fourth United Therapeutics Petition on ANDAs Referencing Tyvaso
CDER Denies Fourth United Therapeutics Petition on ANDAs Referencing Tyvaso
CDER denied a fourth petition from United Therapeutics calling on the center to impose additional conditions before approving ANDAs for combination products that reference its pulmonary arterial hypertension drug Tyvaso unless they meet specific conditions and measured up to the original in terms of performance and bioequivalence.