Corporate News     19-Apr-23
Zydus receives USFDA approval for Roflumilast Tablets
Zydus Lifesciences 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 that leads to chronic obstructive pulmonary disease (COPD). It is used to prevent worsening of symptoms in people with severe 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).

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