Lupin receives USFDA approval for Lenalidomide Capsules
India, Sept. 17 -- Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.Lenalidomide Capsules are bioequivalent to Revlimid' Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, of Bristol-Myers Squibb Company. This product will be manufactured at Lupin's Pithampur facility in India.Lenalidomide Capsules are indicated for the treatment of adult patients with:? -Multiple myeloma (MM), in combination with dexamethasone? - MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)? - Transfusion-dependent anemia due to low- or intermedia...
To read the full article or to get the complete feed from this publication, please
Contact Us.