Zydus Pharmaceuticals (USA) Inc gets final US FDA approval to market Roflumilast tablets

Cadlia Healthcare Ltd on Monday said group firm Zydus Pharmaceuticals (USA) Inc has received final approval from the US health regulator 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.

Zydus, being one of the first applicants for Roflumilast Tablets, 500 mcg, is eligible for 180 days of shared generic drug exclusivity, Cadlia Healthcare said in a regulatory filing.

The US Food and Drug Administration (USFDA) has also given a tentative approval for Roflumilast tablets, 250 mcg, the company added.


The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

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, it added.

The group now has 327 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.