Lupin receives USFDA’s nod for Zileuton Extended-Release Tablets
11th Nov 2019

Lupin has received approval for its Zileuton Extended-Release Tablets, 600 mg, from the United States Food and Drug Administration (USFDA), 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 sales of approximately $43 million in the US. (IQVIA MAT September 2019).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.