New Delhi, Sep 18
Indian pharma major Lupin announced that the US Food and Drug Administration has approved its abbreviated new drug application for Lenalidomide capsules in strengths of 2.5 mg to 25 mg for cancer patients.
Lenalidomide has been approved for treatment of adult patients with multiple myeloma -- a deadly blood cancer -- when used with dexamethasone as maintenance therapy after autologous haematopoietic stem cell transplantation, the company said in an exchange filing.
It is also indicated for transfusion-dependent anaemia in low- or intermediate-1-risk myelodysplastic syndromes linked to a deletion 5q abnormality.
Lenalidomide capsules are a generic version of Revlimid capsules, developed by American multinational Bristol-Myers Squibb Company.
The product will be manufactured at Lupin’s Pithampur facility in Madhya Pradesh, the statement added.