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FDA Approves Ravicti for Urea Cycle Disorders

FDA Approves Ravicti for Urea Cycle DisordersFRIDAY, Feb. 1 (HealthDay News) -- Ravicti (glycerol phenylbutyrate) has been approved by the U.S. Food and Drug Administration to treat certain urea cycle disorders (UCDs) in people 2 years and older.

These inherited conditions involve a lack of enzymes that help the body remove ammonia from the blood. In people with UCDs, ammonia build-up can lead to coma, brain damage, or death, the FDA said Friday in a news release.

Ravicti is a liquid taken three times daily with meals. It's been approved for people whose disorders cannot be managed by a protein-restricted diet or amino acid supplements alone, the agency said.

Ravicti was compared to another UCD drug in a clinical study involving 44 adults. The most common side effects of the new drug were diarrhea, flatulence, and headache.

Ravicti is marketed by Hyperion Therapeutics, based in San Francisco.

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