Domestic pharma firm Lupin on Friday said it has received approval from the US health regulator for its generic Zileuton extended-release tablets used as prophylaxis and in treatment of chronic asthma.
The approval by the US Food and Drug Administration (USFDA) is for Zileuton extended-release tablets of strength 600 mg, which is the generic equivalent of Zyflo CR of Chiesi USA, Inc, Lupin said in a regulatory filing.
The medicine is indicated for prophylaxis and treatment of chronic asthma in adults and children 12 years of age and older, it added.
Citing IQVIA MAT September 2019 data, the company said Zileuton extended-release tablets, 600 mg had annual sales of approximately $43 million in the US.
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