Bio News
Generic version of Horizon’s Ravicti receives abbreviated new drug application approval
Global pharmaceutical company Lupin has received approval from the U.S. Food and Drug Administration (FDA) for a generic treatment for urea cycle disorders (UCDs), a market valued at $337 million annually. The approved glycerol phenylbutyrate oral solution, 1.1 g/mL, is bioequivalent to Horizon Therapeutics’ Ravicti. With the approval of the abbreviated new drug application (ANDA), Lupin plans to enter the market for treatments for patients with UCDs whose condition cannot be adequately managed through protein dietary restriction alone.
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