New Delhi: Drug firm Zydus Cadila on Tuesday said it has received final approval from US health regulator for generic Mesalamine delayed-release tablets used for treatment of ulcerative colitis.
The company has received final approval from the United States Food and Drug Administration (USFDA) for Mesalamine delayed-release tablets in the strength of 800 mg, Zydus Cadila said in a statement.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, it added.
The group has received 27 final abbreviated new drug application (ANDA) approvals from the USFDA and 2 tentative ANDA approvals since January 2017, Zydus Cadila said.
The group now has more than 130 approvals and has so far filed over 300 ANDAs since the commencement of the filing process, it added.
Mesalamine delayed-release tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.