Amneal Pharmaceuticals has announced the launch of Mesalamine 800 mg delayed-release tablets to treat moderately active ulcerative colitis in adults.
The company also received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for generic lenalidomide (marketed as Revlimid) capsules.
Available in six strengths, which include 2.5mg, 5mg, 10mg, 15mg, 20mg, and 25mg, lenalidomide is a thalidomide analogue used to treat various blood cancers.
Revlimid is indicated for adult patients with multiple myeloma and transfusion-dependent anaemia caused by myelodysplastic syndromes (MDS).
In a settlement of all pending claims, Celgene has granted Amneal a license to manufacture and sell generic lenalidomide in the US starting on 31 January 2026.
Amneal affordable medicines chief commercial officer and executive vice president Andy Boyer said: “Our ability to execute and continuously launch complex products is expanding our portfolio of affordable medicines and driving the sustainable growth of our business.
“Mesalamine is a difficult to make product with a limited number of suppliers, and this approval highlights the strength of our R&D capabilities.
“Additionally, the approval of lenalidomide represents another key product approval in a large market that will be a future growth driver for us.”
Nasdaq-listed Amneal develops, manufactures and distributes over 280 pharmaceuticals, mainly in the US. Its affordable medicines segment covers complex products like injectables and biosimilars.
In the speciality segment, the biopharmaceutical company focuses on branded pharmaceuticals for central nervous system and endocrine disorders.
Through the AvKARE segment, Amneal distributes pharmaceuticals and other products to the US federal government, retail, and institutional markets.
Last month, the biopharmaceutical company secured FDA approval for memantine/donepezil 14-10mg and 28-10mg extended-release capsules, referencing Abbvie’s Namzaric.
It also secured approval for everolimus capsules, referencing Novartis’ Afinitor Disperz and tentative approval for rifaximin tablets, referencing Bausch Health’s Xifaxan.
