Zydus gets FDA approval for COPD drug Roflumilast Tablets

Zydus Group said that its subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) to market Roflumilast Tablets in 500mcg strength and tentative approval for Roflumilast Tablets in 250mcg.

Roflumilast Tablets is the generic version of Dalires.

Zydus said that as it is one of the first applicants for Roflumilast Tablets, the 500mcg product is eligible for 180 days of shared generic drug exclusivity.

Zydus gets FDA approval for COPD drug Roflumilast Tablets. Photo courtesy of Zydus Cadila.

Roflumilast Tablets have the approval to be used for cutting down the chances of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD related to chronic bronchitis and a history of exacerbations.

The COPD drug will be manufactured at Zydus formulation manufacturing facility in Ahmedabad.