Lupin receives final approval for Zileuton Extended-Release Tablets
Capital MarketLupin 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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