genglob magazine

Hyderabad based NATCO Pharma Limited today confirmed that the company has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market lenalidomide capsules in 5, 10, 15 and 25mg strengths prior to the expiration of various U.S. patents. NATCO’s lenalidomide capsules are the generic version of Celgene Corporation’s Revlimid®.

On August 30, 2010, pursuant to the Hatch-Waxman Act, NATCO notified Celgene that its ANDA requesting approval from the FDA for a generic version of Revlimid® contained a paragraph IV certification asserting that various Revlimid® patents are invalid, unenforceable and/or not infringed. Lenalidomide, which is presently marketed as Revlimid by Celgene, is a derivative of thalidomide and is used in the treatment for multiple myeloma. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Read the rest of this entry »

The initial data from a Phase III study using the Revlimid in multiple myeloma patients who had undergone stem cell transplant reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression. Read the rest of this entry »

The combination of the immunomodulatory drug lenalidomide and the proteasome inhibitor bortezomib appears to be both safe and potentially able to induce durable responses in patients with relapsed or relapsed/refractory multiple myeloma, U.S. researchers report online in the Journal of Clinical Oncology. Read the rest of this entry »