Zydus’ U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the USFDA to market Roflumilast Tablets in the strength of 500 mcg and a tentative approval for Roflumilast Tablets, 250 mcg (US RLD for Roflumilast Tablets, 500 mcg is DALIRESP ® ).
Zydus being one of the first applicants 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 w ith severe COPD associated with chronic bronchitis and a history of exacerbations. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
The group now has 327 approvals and has so far filed over 400 ANDAs commencement of the filing process in FY 2003-04.