Last Updated on October 17, 2024 by The Health Master
A statement from Alembic Pharma notified that the US Food and Drug Administration (USFDA) today gave final approval to Alembic Pharma for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.
According to the statement, Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Apriso extended-release capsules, 0.375 g, of Salix Pharma.
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