Lupin announced the launch of Zileuton extended-release tablets, 600 mg, having received an approval from the United States Food and Drug Administration (US FDA) earlier. The product would be manufactured at Lupin’s Nagpur facility, India.
Zileuton extended-release tablets, 600 mg, is the generic equivalent of Zyflo CR extended-release tablets, 600 mg, of Chiesi USA, and is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Zileuton extended-release tablets had annual sales of approximately $40 million in the US (IQVIA MAT June 2020).