Latest News | Alembic Pharma Receives Final Approval from USFDA for Generic Mesalamine Extended-release Capsules

New Delhi, Nov 2 (PTI) 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.

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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.

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(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)