USFDA gives approval for this Genetic Disorder drug

UCD is a genetic condition that causes toxic ammonia to build up in the blood due to the deficiency of certain enzymes.

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USFDA Approval
USFDA Approval

Last Updated on October 6, 2024 by The Health Master

Texas: The US Food and Drug Administration (USFDA) has approved Acer Therapeutics Inc’s drug for treating patients with urea cycle disorders (UCDs), according to the health regulator’s website.

The approval letter said the drug, sodium phenylbutyrate, could be used as an adjunctive therapy to the standard of care for patients with UCDs with certain deficiencies.

UCD is a genetic condition that causes toxic ammonia to build up in the blood due to the deficiency of certain enzymes.

The company resubmitted its marketing application for the drug in July after getting the so-called “complete response letter” from the USFDA in June.

The company did not immediately respond to a Reuters request for comment about the drug’s pricing and availability.

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