Zydus’ US subsidiary Zydus Pharmaceuticals (US) Inc has received final approval from the US Food and Drug Administration (FDA) to market Roflumilast tablets in the strength of 500 mcg and a tentative approval for Roflumilast tablets, 250 mcg (US RLD – DALIRESP), the company notified via a statement.
Zydus being one of the first applicants for Roflumilast tablets, 500 mcg, is eligible for 180 days of shared generic drug exclusivity under section 505(j)(5)(B)(iv) of the FD&C 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, added the statement.
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, the statement concluded.