Zydus Cadila receives US FDA approval for mesalamine ER capsules

PSM News /

Mumbai, August 14, 2021:

 

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market mesalamine extended-release capsules in the strength of 0.375 g.

 

Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

 

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

 

The group now has 320 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04. PharmaBiz