Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Abraxis BioScience has received two approvals from FDA to market the liquid and lyophilized versions of fludarabine phosphate for the treatment of adult patients with B-cell chronic lymphocytic leukemia.
Subscribe to our email newsletter
The lyophilized version of fludarabine, which is the generic equivalent of Fludara (fludarabine phosphate) for injection distributed by Bayer HealthCare Pharmaceuticals, will be packaged in 50mg/2mL single-dose vials. The liquid version of fludarabine, which is the equivalent of fludarabine phosphate for injection marketed by Teva Parenteral Medicines, will be packaged in a 50mg single dose vial.
Fludarabine is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of fludarabine in previously untreated or non-refractory patients with CLL have not been established.
Fludarabine, which interferes with the process of leukemia cell growth, has been proven effective in clinical trials among patients who did not benefit from chemotherapy with alkylating agents.