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Last Updated : Nov 08, 2019 05:55 PM IST | Source: PTI

Lupin gets USFDA nod for generic chronic asthma treatment drug

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.

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.

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Citing IQVIA MAT September 2019 data, the company said Zileuton extended-release tablets, 600 mg had annual sales of approximately USD 43 million in the US.

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First Published on Nov 8, 2019 05:47 pm
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