Amneal Launches Mesalamine And Secures FDA Approval For Generic Lenalidomide

Amneal Pharmaceuticals maintains its position as a well-known biopharma company throughout the global market. The company announced its new product release of mesalamine 800 mg delayed-release tablets, which serve to treat moderately active ulcerative colitis in adults. The company received FDA approval to market its Abbreviated New Drug Application (ANDA) formulation of lenalidomide capsules in various dosages starting from 2.5 to 25 mg. Lenalidomide functions as a thalidomide derivative for blood cancer therapy.

As part of a legal settlement, Celgene has granted Amneal a license to manufacture and sell generic lenalidomide in the U.S. starting January 31, 2026. Lenalidomide, also marketed as REVLIMID®, is indicated for multiple myeloma and transfusion-dependent anaemia due to myelodysplastic syndromes (MDS). The most common adverse reactions reported while lenalidomide was used include neutropenia, thrombocytopenia and leukopenia. 

ASACOL HD® 800 mg is the brand name for mesalamine, and the commonly reported side effects include headache, stomach pain, burping, nausea, sore throat, dizziness, weakness, and diarrhoea. Less commonly, patients have experienced chest pain, menstrual cramps, swelling in the limbs, skin rash, and worsening of colitis. The U.S. annual sales for mesalamine 800 mg for the 12 months ended December 2024 were approximately $147 million, data estimated by IQVIA®