Lupin receives final approval for Zileuton Extended-Release Tablets

Lupin announced that it has received approval for its Zileuton Extended-Release Tablets, 600 mg, from the United States Food and Drug Administration (U .S. FDA), to market a generic equivalent of Zyflo CR Extended-Release Tablets, 600 mg, of Chiesi USA, Inc.

Lupin's Zileuton Extended-Release 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 sa les of approximately USD 43 million in the U.S. (IQVIA MAT September 2019).

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