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MARCH 5, 2025

Amneal Receives FDA Approval for Lenalidomide


Amneal Pharmaceuticals Inc. has received approval from the FDA for its Abbreviated New Drug Application for lenalidomide capsules in 2.5-, 5-, 10-, 15-, 20- and 25-mg strengths. 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 United States beginning on Jan. 31, 2026. Lenalidomide is indicated for the treatment of several blood cancers.