Zydus gets 180 days’ shared exclusivity for Roflumilast tablets
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
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.
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