Alembic Pharma announced today that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals.
These capsules are used for the maintenance of remission of ulcerative colitis in adults.
Mesalamine Extended-Release Capsules USP, 0.375 g, have an estimated market size of US$ 133 million for twelve months ending June 2022 according to IQVIA.
Alembic has a cumulative total of 174 ANDA approvals (150 final approvals and 24 tentative approvals) from USFDA.
The stock price has reacted positively to this news, rising 7% to hit an intraday high at Rs.619.20 on the back of a very robust surge in volume. Its 52-week high is at Rs.847.95.