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Zydus-Cadila gets US approval for roflumilast tablets for COPD

Ahmedabad-based drug maker Zydus Cadila said that it has received final approval from the US drug regulator, Food and Drug Administration, to market its generic version of roflumilast tablets in the strength of 500 mcg indicated to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad SEZ. Roflumilast tablets would help reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

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