Financial Wire

Aurobindo Pharma Gets US FDA's Final Nod for Glycerol Phenylbutyrate Oral Liquid

-- Aurobindo Pharma (NSE:AUROPHARMA, BOM:524804) has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, according to a Friday filing to the Indian stock exchanges.

The drug is bioequivalent and therapeutically equivalent to Horizon Therapeutics' reference-listed drug Ravicti Oral Liquid. It will be manufactured in the company's third unit and will be launched immediately.

Glycerol Phenylbutyrate is used as a nitrogen-binding agent for chronic management of patients with urea cycle disorders.

According to IQVIA's estimates, Horizon has an estimated market size of $50.2 million for the 12 months ended February.

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Aurobindo Pharma Gets US FDA's Final Nod for Glycerol Phenylbutyrate Oral Liquid | Financial Wire