Zydus receives USFDA tentative approval for Roflumilast Tablets

17 Oct 2022 , 11:48 AM

Zydus Lifesciences U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Roflumilast Tablets USP, 250 mcg (USRLD: Daliresp?). Roflumilast Tablets are indicated as a treatment to reduce the risk of Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The drug will be manufactured at the groups formulation manufacturing facility at Ahmedabad SEZ, India. Roflumilast Tablets had annual sales of USD 248mn in the United States according to IQVIA data (IQVIA MAT Aug 2022).Powered by Capital Market – Live News