Drug firm Zydus Cadila on Friday said it has received approval from the US health regulator to market Mesalamine extended-release capsules in the American market. Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
The company has received final approval from the US Food and Drug Administration (USFDA) to market the capsules in the strength of 0.375 g, Zydus Cadila said in a statement. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, the drug maker noted.
The group now has 320 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since it started the filing process in FY 2003-04.
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