Zydus Lifesciences on Wednesday said that it has received final approval from the United States Food and Drug Administration (US FDA) to manufacture and market generic Roflumilast Tablets used as an anti-inflammatory drug.
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 pharmaceutical company in a regulatory filing on exchanges said, "Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) 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)."
The drug will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad, (India), the company said.
Roflumilast Tablets, 250 mcg had annual sales of USD 34 million in the United States (IQVIA MAT Feb. 2023).
Shares of Zydus Lifesciences were trading 0.05 percent up at Rs 516.20 per share at 3:23 pm today on NSE.
