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.

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.