Zydus receives USFDA approval to market Roflumilast Tablets 500 mcg

20 Feb 2022 , 01:35 AM

Zydus US subsidiary Zydus Pharmaceuticals USA Inc has received final approval from the USFDA to market Roflumilast Tablets in the strength of 500 mcg and a tentative approval for Roflumilast Tablets 250 mcg US RLD – DALIRESP Zydus being one of the first applicants for Roflumilast Tablets 500 mcg is eligible for 180 days of shared generic drug exclusivity under section 505j5Biv of the FDC Act Zydus 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 The drug will be manufactured at the groups formulation manufacturing facility at the SEZ Ahmedabad