Zydus Lifesciences gets final USFDA approval to manufacture generic anti-inflammation drug

New Delhi, April 19

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to manufacture and market its generic Roflumilast tablets used in reducing inflammation in the lungs.

The approval granted by the United States Food and Drug Administration (USFDA) is for manufacturing and marketing of Roflumilast tablets of strength 250 mcg, the company said in a regulatory filing.

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

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