Amneal Launches Mesalamine for Ulcerative Colitis, Receives Lenalidomide FDA Approval

Amneal Pharmaceuticals has announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis (UC) in adult patients.1

According to a February 19, 2025, press release from the company, in addition to the launch of the 5-aminosalicylic acid (5-ASA) referencing ASACOL HD®, the US Food and Drug Administration has approved Amneal’s Abbreviated New Drug Application for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg doses for the treatment of blood cancers.1

“Our ability to execute and continuously launch complex products is expanding our portfolio of affordable medicines and driving the sustainable growth of our business,” said Andy Boyer, executive vice president and chief commercial officer of affordable medicines at Amneal Pharmaceuticals.1 “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.”

In January, the FDA granted tentative approval to Amneal Pharmaceuticals’ rifaximin 550 mg oral tablets, which references Bausch Health’s Xifaxan, for the treatment of adults with irritable bowel syndrome with diarrhea.2 Now, just weeks later, the company has announced the launch of a generic UC drug.1

In 2007, the FDA approved mesalamine (Lialda) for the induction of remission in patients with active, mild to moderate UC, making it the first and only FDA-approved once-daily oral formulation of mesalamine at the time. With the approval, the drug became the first new mesalamine treatment to enter the market since 2000 and allowed patients to take as few as 2 tablets once daily, while other available mesalamines required 3 to 4 times daily dosing and 6 to 16 pills per day.3

According to the release from Amneal, the most common side effects reported with mesalamine 800 mg delayed-release tablets include headache, stomach pain, burping, nausea, sore throat, dizziness, weakness, and diarrhea. Less commonly, patients have experienced chest pain, menstrual cramps, swelling in the limbs, skin rash, and worsening of colitis.1

In 2005, the FDA approved lenalidomide (Revlimid) for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.4 Some of the most common adverse reactions reported with lenalidomide use include neutropenia, thrombocytopenia, and leukopenia.1

According to Amneal Pharmaceuticals, in settlement of all outstanding claims related to this product, Celgene agreed to provide Amneal with a license to Celgene’s patents required to manufacture and sell generic lenalidomide in the US beginning on January 31, 2026.1

References

1. Amneal Pharmaceuticals. Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide. February 19, 2025. Accessed February 19, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Launches-Mesalamine-and-Receives-U.S.-FDA-Approval-for-Lenalidomide/default.aspx

2. Brooks A. FDA Grants Tentative Approval to Generic Version of Rifaximin for IBS-D. HCPLive. January 23, 2025. Accessed February 19, 2025. https://www.hcplive.com/view/fda-grants-tentative-approval-generic-version-rifaximin-ibs-d

3. Drugs.com. FDA Approves Lialda (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis. January 16, 2007. Accessed February 19, 2025. https://www.drugs.com/newdrugs/fda-approves-lialda-mesalamine-first-oral-once-daily-mesalamine-patients-active-mild-moderate-317.html

4. Drugs.com. FDA Grants Revlimid NDA Approval. December 28, 2005. Accessed February 19, 2025. https://www.drugs.com/newdrugs/fda-grants-revlimid-nda-approval-4984.html