East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Roflumilast Tablets, 500 mcg. Aurobindo Pharma’s Roflumilast Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), DALIRESP® Tablets manufactured by Astrazeneca Pharmaceuticals LP.

Roflumilast Tablets are indicated as:

• A treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.