UtilityTherapeutics announces FDA acceptance of PIVYA new drug application with priority review

Utility Therapeutics

17 January 2024 - Utility has received a Prescription Drug User Fee Act target action date of 24 April 2024.

Utility Therapeutics today announced announced that the US FDA has accepted its new drug application for Pivya (pivmecillinam) for the treatment of uncomplicated urinary tract infections.

Read Utility Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier