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Pharma major Lupin Limited has received United States Food and Drug Administration (FDA) approval for zileuton extended-release tablets, 600 mg, to market a generic equivalent of Zyflo CR extended-release tablets, 600 mg, of Chiesi USA, Inc.
Lupin’s zileuton ER tablets, 600 mg are indicated for prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Zileuton extended-release tablets, 600 mg had annual sales of approximately US$ 43 million in the US (IQVIA MAT September 2019).
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