Zydus Pharma Roflumilast Tablets bags USFDA okay to treat COPD exacerbations

Ahmedabad: Zydus Lifesciences Limited's (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 (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.

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable chronic lung disease which affects men and women worldwide.

Abnormalities in the small airways of the lungs lead to limitation of airflow in and out of the lungs. Several processes cause the airways to become narrow. There may be destruction of parts of the lung, mucus blocking the airways, and inflammation and swelling of the airway lining.

COPD is sometimes called emphysema or chronic bronchitis. Emphysema usually refers to destruction of the tiny air sacs at the end of the airways in the lungs. Chronic bronchitis refers to a chronic cough with the production of phlegm resulting from inflammation in the airways. 

The drug will be manufactured at the group's 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). 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.

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