Zydus Lifesciences bags USFDA nod for pulmonary drug Roflumilast

Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Roflumilast Tablets, 250 mcg (USRLD: Daliresp Tablets, 250 mcg).

Roflumilast reduces inflammation in the lungs which leads to chronic obstructive pulmonary disease (COPD). It is used to prevent worsening of symptoms in people with severe COPD.

Chronic obstructive pulmonary disease is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis. In people with COPD, the lungs can get damaged or clogged with phlegm. Symptoms include cough, sometimes with phlegm, difficulty breathing, wheezing and tiredness. Smoking and air pollution are the most common causes of COPD.

The drug will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad,  India.

Roflumilast Tablets, 250 mcg had annual sales of USD 34 mn in the United States (IQVIA MAT Feb. 2023). The group now has 363 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that the company's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. had received tentative approval from the 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.

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