Lupin gets USFDA nod for generic equivalent of Zyflo CR Extended-Release Tablets to treat prophylaxis, asthma
"Zileuton Extended-Release Tablets, 600 mg are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older, Lupin said in a BSE filing.
New Delhi: Pharma major Lupin Limited (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) for treating prophylaxis and chronic treatment of asthma.
The product is to market a generic equivalent of Zyflo CR Extended-Release Tablets, 600 mg, of Chiesi USA, Inc.
"Zileuton Extended-Release Tablets, 600 mg are indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older, Lupin said in a BSE filing.
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Zileuton Extended-Release Tablets, 600 mg had annual sales of approximately USD 43 million in the U.S. (IQVIA MAT September 2019).
Headquartered in Mumbai, Lupin develops and delivers a range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a global position in the Anti-TB segment.
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