Alembic Pharma receives final approval from USFDA for generic Mesalamine extended-release capsules

Alembic Pharmaceuticals on Wednesday said it has received final approval from the US health regulator for its generic Mesalamine extended-release capsules indicated for the maintenance of remission of ulcerative colitis in adults.

The approval granted by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Mesalamine Extended-Release Capsules of strength 0.375 g, the company said in a statement.

The approved drug is therapeutically equivalent to Salix Pharmaceuticals Inc's reference listed drug (RLD), Apriso extended-release capsules, 0.375 g, it added.


The drug has an estimated market size of USD 133 million for the months ended June 2022, Alembic said citing IQVIA data.