Cadila Healthcare Ltd announced on Monday that its subsidiary Zydus Pharmaceuticals (USA) Inc had received final permission from the US Food and Drug Administration to market its generic version of Roflumilast tablets in the strength of 500 mcg, which is used to lower the risk of COPD exacerbations.
Cadila Healthcare said in a regulatory filing that Zydus, as one of the first applicants for Roflumilast Tablets, 500 mcg, is entitled to 180 days of shared generic medication exclusivity.
According to the company, the US Food and Drug Administration (USFDA) has also given Roflumilast tablets, 250 mcg, a provisional approval.
The drug will be made at the group’s formulation manufacturing facility in Ahmedabad’s Special Economic Zone.
According to the company, roflumilast tablets are used to lower the risk of COPD exacerbations in patients with severe COPD, chronic bronchitis, and a history of exacerbations.
Since the filing procedure in FY 2003-04, the group has received 327 approvals and filed over 400 abbreviated new drug applications (ANDAs).