Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data

Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) 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.

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 group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).

The group now has 326 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.