FDA Approves Generic of Revlimid
Dr. Reddy’s received FDA approval for two strengths of lenalidomide for the treatment of patients with multiple myeloma.
The FDA has approved Dr. Reddy’s abbreviated new drug application for lenalidomide capsules, in 2.5 mg and 20 mg strengths, and given a tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is a therapeutic equivalent generic version of Celgene’s Revlimid, which is an oral cancer drug that is used for the treatment of multiple myeloma.
With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg.
In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug. Celgene agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the United States beginning on a date sometime after March 2022.
Marc Kikuchi
As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the United States without volume restrictions beginning on Jan. 31, 2026.
“We are pleased with the agency’s approval of lenalidomide capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity,” Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories, said in a statement.
Dr. Reddy’s has also launched a generic version of carmustine for injection, a therapeutic equivalent generic version of Emcur Pharmaceuticlal’s BiCNU, a cancer therapeutic used to treat patients with brain tumors, multiple myeloma, Hodgkin disease, and non-Hodgkin lymphoma.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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